Department of rehabilitation services reverse total. Inter and intrasystem size variability of reverse shoulder. The 2016 recall was the fourth involving zimmer or biomet reverse shoulder devices since 2010. Due to shortcomings of the reverse shoulder prosthetics of the time, the djo reverse shoulder prosthesis rsp was designed to create a more anatomic alignment of the shoulder and reduce the. Anyone who underwent shoulder replacement or implant surgery from 2008 through december of 2016 and received a zimmer biomet implant should learn if their device is included. Humeral traytaper failure in modular reverse total.
Six polyethylene inserts each from eight reverse total shoulder arthroplasty systems. The science and art of medical care is to provide the right. Resect the humeral head, and then remove the steinmann pins and cutting block. Deltopectoral approach an incision is made from the tip of the coracoid along the deltopectoral groove, slightly lateral to the axillary fold. Humeral traytaper failure in modular reverse total shoulder. Pdf biomechanics of the reverse shoulder arthroplasty. The removal of osteophytes at this stage will help with visualization of. Super eas heads medialization with retained contact surface on the glenoid total humerus coupler. In cases of severe contracture, subscapularis lengthening. Reverse or inverse total shoulder arthroplasty rtsa is designed specifically for the treatment of glenohumeral gh arthritis when it is associated with irreparable rotator cuff damage, complex fractures as well as for a revision of a previously failed conventional total shoulder. Fda issues class i recall of zimmer biomet reverse shoulder. Biomet, as the manufacturer of this device, does not practice medicine and does not recommend this device or technique. Make a longitudinal incision through the tendinous portion of the subscapularis muscle and capsule, just medial to the lesser tuberosity figure 3. Comprehensive reverse shoulder system zimmer biomet tv.
Focusing exclusively on reverse shoulder arthroplasty rsa techniques and devices, this. It involved reversing the polarity of the ball and the socket by placing a ball component at the glenoid and an articular socket. In rsa or anatomic prostheses total shoulder arthroplasty, humeral. Zimmer biomet recalled certain biomet comprehensive reverse shoulder humeral trays in december 2016 due to the devices having a higher than anticipated fracture rate. Reverse total shoulder arthroplasty shoulder replacement. Food and drug administration fda just released an announcement on a class 1 recall of zimmer biomets comprehensive reverse shoulder system due to issues with the shoulder devices fracturing. A comparison of glenoid fixation using two different reverse shoulder designs with an equivalent center of rotation in a low and high density bone substitute. Both approaches call for anatomically accurate and stable reinsertion of the muscletendon units subscapularis tendon andor the deltoid muscle. This is the highest classification of recall available to the fda and reflects a situation where there is a reasonable. Jul 02, 2015 reverse total shoulder arthroplasty rsa was first described by grammont et al. The comprehensive reverse shoulder system was born from a desire to provide a complete shoulder arthroplasty solution to surgeons, without compromise. The zimmer biomet comprehensive reverse shoulder is a device that is surgically implanted to help patients restore arm movement. Djo surgical reverse shoulder prosthesis rsp request pdf. The driscoll firm, llc, is investigating the failure of the biomet comprehensive reverse shoulder humeral replacement device among those who had the device surgically implanted prior to.
The zimmer biomet shoulder recall affects implants distributed between october 2008 and september 2015, which could have been used in implants up to the date of the recall. Biomechanical summary of reverse shoulder arthroplasty. Distalization of the humerus, resulting in retensioning of the deltoid muscle and any rotator cuff muscles that are still. The recall affects more than 3,600 devices in specific lots that were manufactured before september 2011 and distributed between october 2008 and september 2015. Equinoxe reverse system total shoulder arthroplasty exactech. Biomechanics of the aequalis reversed ii prosthesis is designed for medialization of the center of rotation inside the glenoid bone surface. Pdf the biomet comprehensive reverse total shoulder system design. The shoulder is a ball and socket joint that enables you to raise, twist, bend and move your arms forward, to the sides and behind you. Cases in which a reverse shoulder arthroplasty is indicated as a. Biomet comprehensive reverse shoulder products are indicated for use in patients whose shoulder. Studies of human proportions 1490 this brochure describes the complete set of products and combinations of the smr shoulder system.
After thoroughly cleansing and drying the reverse morse taper, place the polyethylene locking ring over the collar of the stem, resting on the humeral resection line. Shoulder system reversed 11 reverse insert arcom polyethylene available in 4 thicknesses. Food and drug administration fda recently issued its highest level of recall for the zimmer biomet reverse shoulder. This implant has a short metaphyseal stem and is designed exclusively for reverse total shoulders. Reverse total shoulder arthroplasty rtsa is designed specifically for the treatment of glenohumeral shoulder arthritis when it is associated with irreparable rotator cuff damage, complex fractures as well as for a revision of a previously failed conventional total shoulder arthroplasty. In the current climate of deescalation of total shoulder arthro.
Biomet, as a manufacturer of this device, does not practice medicine and does not recommend this device or technique. To learn more about the types of injuries that have been linked to this medical device, and the legal claims. The saw blade should be moving when it comes in contact with the bone figure 10. Hcp content posted july 12, 2016 in animated demonstrations and zimmer biomet extremities. Zimmer biomet volumetric analysis of micro, mini and standard stems using computer aided design software. Zimmer biomet reverse shoulder recall lawsuit lawyer. An anterolateral mckenzie technique can be used as an alternative. Alongside some of the worlds top healthcare professionals, we help deliver new possibilities to patients. The baseplates feature an anatomic shape with six screw hole options and an innovative bone cage that provides initial and biologic fixation 24.
Shoulder inversereverse option offers the ability for pain relief and restoration of function using the same humeral stem used for primary, revision. The comprehensive reverse shoulder has been trusted since 2008. Biomechanical summary of reverse shoulder arthroplasty youtube. Randy clark, md from coral desert orthopedics in st. At zimmer biomet, our innovations help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues. Nowadays, reverse total shoulder arthroplasty rtsa is the treatment of choice for rotator cuff tear arthropathy cta. Pdf humeral traytaper failure in modular reverse total. Zimmer biomet reverse shoulder lawsuit lawyer settlements. The task of repairing complex fractures, or restoring as much range of motion as possible so patients with rotator cuff deficiencies can return to daily activities can be challenging. Zimmer biomet shoulder lawsuit, infection, death, revision. The use of reverse total shoulder arthroplasty rsa is becoming increasingly popular, but many biomechanical aspects are poorly understood. This biomodular shoulder surgical technique is utilized by david m.
February 2017 zimmer biomet composite reverse shoulder humeral trays were recalled due to a higherthanexpected rate of fractures and revision surgery. A total of 3,662 people with these shoulder replacement devices are affected by the recall. Prosthesis design and placement in reverse total shoulder. Reverse shoulder replacements that fracture will need another surgery to replace the broken implant. Comprehensive total shoulder system figure 3 patient positioning and incision identify anterior structures and externally rotate the humerus. Zimmer biomet, the medical device manufacturer of the comprehensive reverse shoulder system previously had to recall other reverse shoulder devices used in surgeries because of product defects. Helping patients harmed by zimmer biomet shoulder replacement device failures. Zimmer biomet shoulder replacement recall for comprehensive. As an adjunct, the video is accompanied with 2 years follow up results as well as our specific staged rehabilitation program. All patients in the cohort received the biomet comprehensive reverse shoulder system biomet, warsaw. Comprehensive reverse shoulder system the comprehensive reverse shoulder builds on the foundation of the comprehensive shoulder system.
The purpose of this work is to show a detailed videodemonstration of the surgical technique at university of florida for this complex pathology. The latest generation of biomet comprehensive reverse shoulder system biomet, warsaw, indiana is manufactured out of cobalt chrome rather than titanium and in revision settings is interchangeable with the original implant. At biomet, we strive to view our work through the eyes of one surgeon and one patient. The agency designated the zimmer biomet shoulder replacement recall class i, which indicates that the affected devices could cause serious injury or death.
Fda issues class i recall of zimmer biomet reverse. Department of rehabilitation services reverse total shoulder. The comprehensive srs system is compatible with comprehensive shoulder components, comprehensive reverse shoulder components, the biomodular shoulder system and the discovery elbow, making it a unique solution to complex cases. Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to. Please check the codes list for the availability of products in your market. The record is updated if the fda identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Total and reverse total shoulder replacement aaron a.
Comprehensive segmental revision total and reverse. Zimmer biomet recent recall of comprehensive reverse shoulder system is class i. The zimmer biomet reverse shoulder received fda approval in 2008 through the controversial 510k premarket approval process, which allows manufacturers to bring products to market if they can show the products are substantially similar to an existing product already being sold and distributed. Zimmerbiomet comprehensive reverse shoulder recalls. Oct 22, 2016 biomet comprehensive reverse shoulder arthroplasty rsa is the result of the combination of the biomet comprehensive shoulder system, based upon a humeral stem component platform, with the different specific parts of the reverse ballandsocket design. Zimmerbiomet comprehensive reverse shoulder recalls drug. Pdf subscapularis in reverse total shoulder arthroplasty. The size 2 is available in 36 mm and 41 mm options the size 3 is 41 mm in diameter the stem optional humeral stem can be the used in cases of poor bone quality. The zimmer biomet comprehensive reverse shoulder replacement has been recalled after reports indicate it proposes a higher risk for fracture than initially stated. Beach chair position with the shoulder positioned sufficiently lateral to allow full arm extension. Smr primary surgical technique 3 smr primary surgical technique index leonardo da vinci. Zimmer biomet understands the demands put on reverse shoulder systems.
Zimmer biomet reverse shoulder recall lawyers osteen. Anterior posterior radiography of a right shoulder a and an illustration of a left shoulder b after reverse total shoulder arthroplasty. Apr 14, 2014 total and reverse total shoulder replacement aaron a. Below are some of our videos explaining the potential dangers of the zimmer biomet reverse shoulder, and especially the connection to its high rate of failure. At biomet, we strive to view our work through the eyes of.
Comprehensive reverse shoder sstem indications biomet comprehensive reverse shoulder products are indicated for. The superior lateral approach relies on a deltoid split similar to a rotator cuff. Reverse total shoulder arthroplasty technical notes and. This implant is available with both the standard and small shell versions of the altivate reverse stem. Class 1 device recall biomet comprehensive reverse. Common clinical challenges such as scapular notching, a more demanding patient population and polyethylene wear were inputs of the original design rationale, and comprehensive. Biomet comprehensive reverse shoulder products are indicated for. The arcos platform comprehensive solutions that simplify the complex. George utah narrates a video demonstration of a reverse total shoulder arthroplasty shoulder replacement. The glenoid is traditionally the most difficult part of a reverse shoulder procedure due to poor visibility of the scapula for assessment of the glenoid vault and glenoid version, minimal bone for fixation of the implants and determination of deltoid tensioning.
Comprehensive reverse shoulder system figure 10 place a saw blade through the cutting slot in the guide. Reverse total shoulder arthroplasty and workrelated outcomes. Weve engineered innovation into each component of our reverse shoulder systems. Reverse total shoulder arthroplasty rsa was first described by grammont et al. Pdf background reverse total shoulder arthroplasty rtsa provides reconstructive options in. It is designed for use as a primary reverse prosthesis, or to convert to a reverse from a wellfxed comprehensive primary, revision or fracture stem.
To learn more about the types of injuries that have been linked to this medical device, and the legal claims that have been filed, click zimmer biomet reverse shoulder. The head of the upper arm bone humerus is the ball and a circular depression glenoid in the shoulder bone scapula is the socket. Zimmer biomet comprehensive reverse shoulder replacement. There are two possible surgical approaches to the shoulder for reverse arthroplasty. Equinoxe reverse system total shoulder arthroplasty. Biomet, warsaw, in, usa allows all shoulder arthroplasties to be performed using the same humeral component. A cobalt alloy glenosphere is the recommended component for reverse shoulder arthroplasty patients without material sensitivity to cobalt alloy. Over 1 million times per year, biomet helps one surgeon provide personalized care to one patient. Comprehensive reverse shoulder system superior approach this brochure is presented to demonstrate the surgical technique and postoperative care protocol utilized by david adkison, m. Aequalis reversed ii shoulder system wright medical group. A class i recall is reserved for the most potentially dangerous device or drug defects, those that may cause serious injury or death. This hemiadapter is screwed into the altivate reverse stem and with a turon or altivate anatomic humeral head converts the reverse stem to a hemiarthroplasty prosthesis. Biomet as a manufacturer of this device does not practice medicine and does not recommend this device or technique. They are designed to preserve bone 1 and avoid medializing the joint line by building up the eroded side rather than reaming to correct the deficiency.
News, courses and events form a medical point of view, the verso stemless reverse total shoulder replacement is a real innovation. Comprehensive reverse shoulder system zimmer biomet. Zimmer biomet reverse shoulder lawsuits what you must know. February 11, 2017the fda announced a class 1 recall of the zimmer biomet comprehensive reverse shoulder implant model 115340 based on information that the device is associated with a higher than expected failure rate.
Surgical technique approach to the glenohumeral joint a standardized deltopectoral approach is recommended. The smr anatomic shoulder system is indicated for partali or total, primary or revision shoulder joint replacement in patients. It involved reversing the polarity of the ball and the socket by placing a ball component at the glenoid and an articular socket at the proximal humerus. Zimmer biomets comprehensive reverse shoulder humeral implant is being recalled due to a risk of the shoulder implant fracturing and resulting in the need for revision surgery to remove or replace the failed device. The tess reverse shoulder arthroplasty without a stem in.
It has a proven 112 clinical history, and combines materials that have been tested to withstand the demands of joint arthroplasty. Zimmer biomet comprehensive reverse shoulder implant. Standard stem place the resection guide boom on the. Comprehensive segmental revision total and reverse system. Now, this spirit of innovation lives on through evolved solutions for challenging cases, including comprehensive vault reconstruction system vrs, segmental revision system srs for reverse and. Comprehensive reverse shoulder system total shoulder. Identification of the humeral entry point the humeral head is generally deformed and anatomic reference points may be missing or distorted. Reverse shoulder replacement lawsuits recall information. Innovative design orthopaedics is a young, creative and dynamic company established to provide the best support for healthcare professionals. The humeral entry point is located at the diaphyseal axis at. The biomet comprehensive reverse total shoulder system.
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