Zimmer biomet comprehensive reverse shoulder replacement fracture. The zimmer biomet comprehensive reverse shoulder is a device that is surgically implanted to help patients restore arm movement. We also launched zimmer biomet signature solutions, a comprehensive offering of clinical services and technologies designed to assist hospitals, ambulatory surgery centers and medical practices to succeed in todays valuebased reimbursement environment. The zimmer biomet comprehensive reverse shoulder humeral tray model 115340 was supposed to help patients regain mobility often loss from rotator cuff injuries, arthritis induced arthropathy, or a previously failed shoulder joint replacement. Shoulder, elbow, and wrist replacement implants use metal alloys and polyethylene plastic to restore motion and reduce or eliminate pain. Zimmer biomet recalls comprehensive reverse shoulder due. Comprehensive total shoulder system figure 4 standard, mini, and micro stem technique figure 5 figure 6 humeral preparation using the 4, 5 or 6 mm starter reamer and ratcheting thandle, bore a pilot hole through the humeral head along the axis of the humeral shaft, just lateral to the heads articular surface and just medial to the rotator. Approximately 55 percent of all shoulder replacements are the result of complex fractures of the proximal humerus. Country warsaw, in 46582 department of health and human services food and drug administration dates of inspection 4920184242018 fei number 1825034 global quality and regulatory affairs street address 56 e bell dr type establisment inspected medi cal devi ce b. In the recall notice, zimmer biomet said its comprehensive reverse shoulder system humeral tray model 115340 suffered a high fracture rate. At zimmer biomet, our innovations help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues. Reverse shoulder replacement lawsuits recall information. Biomet comprehensive reverse shoulder products are intended for total.
Zbh comprehensive reverse shoulder system over issues with the. Signature glenoid positioning guide for comprehensive. More information on the comprehensive reverse shoulder recall and the affected devices can be found here in light of the recall, many patients have questions and want to know what they should do. Delegates are kindly invited to bring a case which can be discussed with a faculty member.
Comprehensive reverse shoulder system the comprehensive reverse shoulder system is the next generation reverse shoulder prosthesis, of the comprehensive reverse shoulder story the goal was simple. Review the practical and technical aspects of the zimmer biomet reverse shoulder solutions perform the different or techniques using anatomical specimens the primary aim of the course is to ensure the safe and effective use of zimmer biomet implants. Request pdf the biomet comprehensive reverse total shoulder system design considerations and surgical techniques the biomet comprehensive. Zimmer biomet comprehensive reverse shoulder replacement. Food and drug administration fda issued a public notice saying it had started the most serious type of medical device recall for the biomet comprehensive reverse shoulder system humeral tray model 11530. The comprehensive shoulder system was developed in conjunction with david dines, m. The implant is designed to enable surgeons to repair broken bone while replacing the damaged shoulder joint. Fda class i recall issued for zimmer biomet reverse. Fractures may result in revision surgeries which could cause serious adverse health consequences such as permanent loss of shoulder function, infection, or rarely, death. These options provide intraoperative flexibility, even in complex revision cases.
An estimated 90 percent of all shoulder replacements should last 10 years or more, so the fda pays attention when implanted devices fail within just a few years of implantation, such as in the case of the zimmer biomet comprehensive reverse shoulder system. In addition to those specified above, the proximal. Zimmer biomet has issued three recalls of the comprehensive reverse shoulder implant, due to risks of fracture or defective locking rings. The arcos platform comprehensive solutions that simplify the complex. The process allows device manufacturers to market a new medical device so long as they can show it is substantially equivalent to an existing fdaapproved device. Zimmer biomet shoulder lawsuit, infection, death, revision. Zimmer biomet recalls comprehensive reverse shoulder. Comprehensive reverse shoulder system zimmer biomet.
Zimmer biomet at zimmer biomet, our innovations help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues. The system uses innovative technologies to allow intraoperative flexibility, unmatched humeral stem options, and infinite humeral head offset possibilities. The implants are designed to create a new, smoothly functioning joint that can prevent painful boneonbone contact. 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. Biomet comprehensive shoulder implant lawsuit claims. Signature glenoid positioning guide for comprehensive shoulder software webbased planning software pc and tablet app to develop patientspecific glenoid positioning guides offers both anatomic and reverse shoulder arthroplasty planning allows highresolution 3d visualization guides a dualtrajectory guide affords surgeons. Zimmer biomet comprehensive reverse shoulder implant. The fda this week released information on a class 1 recall of zimmer biomets nyse.
Device manufacturer 510k number comprehensive reverse shoulder mini baseplate biomet, inc. Shoulder replacement prostheses are indicated for use. Associated component involved comprehensive shoulder stem b 4. The fda recently issued a class i recall for the zimmer biomet comprehensive reverse shoulder system humeral tray model 115340.
Zimmer biomet is being sued because its reverse shoulder implant has been failing at a rate higher than the company initially revealed. Zimmer biomet shoulder replacement recall for comprehensive. Hcp content posted july 12, 2016 in animated demonstrations and zimmer biomet extremities. The position of the resection guide boom on the reamer shaft, along with the calibrated reaming depth and stem choice, are directly related. The comprehensive srs system is compatible with comprehensive shoulder. These results support the surface cement technique with a modular gritblasted titanium surface and cruciform stem during primary tka. For the complete comprehensive fracture stem technique, please see boi0274. Comprehensive reverse shoulder system zimmer biomet tv. Biomet has received two complaints of this problem. Three steps that all patients of the zimmer biomet.
The versadial humeral head prosthesis is intended for use only with the comprehensive shoulder stems. Zimmer biomet offers surgeons knee replacement solutions, with a comprehensive suite of orthopaedic knee implant products and instruments. Comprehensive total shoulder system surgical technique. Comprehensive reverse shoulder system the comprehensive reverse shoulder builds on the foundation of the comprehensive shoulder system. Comprehensive fracture system preoperative planning evaluate xrays of both the fractured shoulder and the contralateral shoulder. K080642 equinoxe reverse total shoulder system exactech, inc. In september 2010, biomet recalled about 45 of the comprehensive reverse shoulders due to fractures between the trunnion and baseplate. The agency designated the zimmer biomet shoulder replacement recall class i, which indicates that the affected devices could cause serious injury or death. Mbf prosthesis, shoulder, semiconstrained, metalpolymer, uncemented 21 cfr 888.
Zimmer biomet reverse shoulder recall lawsuit lawyer. We also launched zimmer biomet signature solutions, a comprehensive offering of. In december 2016, zimmer biomet issued an urgent medical device safety warning pdf about the risk of fractures with comprehensive reverse shoulder replacements made before. Zimmer biomet reverse shoulder lawsuit lawyer settlements. Biomet comprehensive reverse shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe. 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. Request pdf the biomet comprehensive reverse total shoulder system design considerations and surgical techniques the biomet comprehensive reverse shoulder arthroplasty rsa is newer. Signature glenoid positioning guide for comprehensive shoulder. The comprehensive segmental revision system srs utilizes a multioption approach to address proximal, distal and total humeral replacement with the convenience of an allinclusive system. Jul 12, 2016 comprehensive reverse shoulder system. Phoenix, arizonaon december 20, 2016, zimmer biomet announced a recall of its comprehensive reverse shoulder implant based on a higherthanexpected fracture rate. Zimmer biomet recalls comprehensive reverse shoulder replacement. Externally rotate and extend the humerus to expose the humeral head, while protecting the.
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. K120121 comprehensive reverse shoulder biomet, inc. Mini stem technique intramedullary resection guide assembly place the. Fractured devices can require painful removal surgery, as well as infection, permanent loss of shoulder function, or death.
If using the micro stem, specialorder micro broaches are required. Yom firms zimmer biomet environmentally controlled room specifications standard operating procedme, sop 9. Comprehensive nano stemless shoulder zimmer biomet. Ensure both xrays are at the same degree of external rotation. Comprehensive segmental revision total and reverse. Remove the drill from the pin, leaving the pin in place.
The cause of the bending fatigue could not be determined. The fact that zimmer biomet had its comprehensive reverse shoulder approved without any human testing likely comes as a shocking surprise. Zimmer biomet comprehensive shoulder implant lawsuit claims. However, the device has proven to be dangerous and the fda initiated a recall for the devices high rate of fracture and risk of death to patients.
Zimmer biomet comprehensive reverse shoulder system. The comprehensive fracture, and revision and micro stems figure 22 are compatible with the comprehensive reverse shoulder. In addition to those specified above, the proximal shoulder replacement prostheses are indicated for use in oncology applications, complex humeral fractures and revisions. The comprehensive reverse shoulder system was designed to provide a complete, seamless system based on the comprehensive shoulder platform. The biomet comprehensive reverse shoulder system received fda approval through the agencys 510k process on december 12, 2007. Zimmer biomet reverse shoulder lawsuits what you must know.
In december 2016, zimmer biomet recalled 3,662 reverse shoulder components of its comprehensive model line. The device is often used to treat patients with rotator cuff tears who suffer from a severe type of shoulder arthritis known as arthropathy, as well as those who have experienced failure of a previous shoulder replacement. Zimmer biomet comprehensive reverse shoulder system is being recalled because of high fracture rate. K110708 comprehensive reverse shoulder titanium glenosphere biomet, inc k53 k172502 p. Determine amount of comminution and proximal bone loss on xray andor ct scans.
Biomet comprehensive reverse shoulder products are indicated for use in patients whose shoulder. You will see in the diagram below, the device puts the ball on the shoulder glenohumeral joint and the socket on the end of the upper arm humeral head, which. Comprehensive total shoulder system versadial humeral heads infinite offset options between 0. Instead of improving arm movement, however, the implant caused several problems and, on december 20, 2016. The comprehensive total shoulder system is an evolutionary design based on the successful clinical heritage of the biomodular shoulder system. The comprehensive shoulder system shoulder education. Zimmer biomet marketed its medical device as a way to help restore a patients natural arm movement, especially individuals who had suffered a rotator cuff tear known as cuff tear arthropathy a severe type of shoulder arthritis, and who failed to. Alongside some of the worlds top healthcare professionals, we help deliver new possibilities to patients. In both cases, the patient did not comply with the warnings in the package insert. In both cases, the patient did not comply with the warnings in. Zimmer biomet s comprehensive total shoulder system design is based on the successful clinical heritage of the biomodular shoulder system. The patient was placed in the beach chair position and a deltopectoral approach was utilized after administration of general anesthesia in combination with an interscalene block.
All procedures were performed by the senior surgeons using the biomet reverse comprehensive shoulder system warsaw, indiana. Zimmer biomet is recalling the comprehensive reverse shoulder because these devices are fracturing at a higher rate than is stated in the labeling. The comprehensive shoulder stems fracture, primary. Patients harmed by biomets comprehensive reverse shoulder system may be able to seek compensation for medical expenses, wages lost and other damages in the form of a biomet comprehensive lawsuit. Comprehensive reverse shoder sstem indications biomet comprehensive reverse shoulder products are indicated for. It was one of the largest recalls of reverse shoulder devices in recent years.
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