Reverse shoulder replacement lawsuits recall information. Zimmer biomet recall of comprehensive reverse shoulder. Tip squeeze your shoulder blades together as you pull. Zimmer biomet announces fda clearance of the comprehensive. Fda provides update on recall of zimmer biomet shoulder implant the fda has provided additional information to patients and medical providers regarding the recall of the comprehensive reverse shoulder implant initiated by zimmer biomet. The comprehensive shoulder system was developed in conjunction with david dines, m. Zimmer biomet devices pose fracture risk shoulder implant. Zimmer biomet comprehensive reverse shoulder implant. 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.
Titanium glenospheres are intended for patients with cobalt alloy material sensitivity. The fact that zimmer biomet had its comprehensive reverse shoulder approved without any human testing likely comes as a shocking surprise to many recipients of the device. In addition, the biomet comprehensive shoulder is based upon the concept of an. Zimmer biomet shoulder lawsuit, infection, death, revision. The cause of the bending fatigue could not be determined.
Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to. Why was this shoulder replacement implant recalled. Reversed total shoulder arthroplasty is a popular treatment in rotator cuff arthropathy. The comprehensive reverse shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency. Jul 12, 2016 comprehensive reverse shoulder system. Zimmer biomet recalls comprehensive reverse shoulder due to a. Determine amount of comminution and proximal bone loss on xray andor ct scans.
Court records from the us district court of colorado show that. Biomet comprehensive shoulder implant lawsuit claims. Zimmer biomet shoulder replacement class action for. Zimmer biomet recalled certain biomet comprehensive reverse shoulder humeral trays in december 2016 due to the devices having a higher than anticipated fracture rate. 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.
Fda class i recall issued for zimmer biomet reverse shoulder. The fda this week released information on a class 1 recall of zimmer biomets nyse. In todays business context mergers and acquisitions another common move. Dec 17, 2016 at least one of these shoulder implant lawsuits has reached a resolution. 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. Comprehensive reverse shoder sstem indications biomet comprehensive reverse shoulder products are indicated for. 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. Customers were asked to complete the attached response form and return it along with recalled product to biomet. The comprehensive shoulder stems fracture, primary and revision are intended for use with the biomodular humeral heads and glenoid components and versadial humeral heads. Use an elastic stretch band of comfortable resistance.
Comprehensive fracture system preoperative planning evaluate xrays of both the fractured shoulder and the contralateral shoulder. 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. In addition to those specified above, the proximal shoulder replacement prostheses are indicated for use in oncology applications, complex humeral fractures and revisions. Utilizing innovative technologies, the system is able to allow for surgeon efficiency through intraoperative. Mar 08, 2017 the fda recently issued a class i recall for the zimmer biomet comprehensive reverse shoulder system humeral tray model 115340. In september 2010, biomet recalled about 45 of the comprehensive reverse shoulders due to fractures between the trunnion and baseplate.
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. Comprehensive reverse shoulder system zimmer biomet. Jul 06, 2017 a zimmer biomet shoulder replacement class action lawsuit is an option for those who may been harmed by a recalled comprehensive reverse shoulder. The versadial humeral head prosthesis is intended for use only with the comprehensive shoulder stems. On september 4, 20, biomet orthopedics, llc, announced the first clinical use in the u. Biomet sent an urgent medical device recall notice letter dated april 29, 2015 to affected customers via fedex. The biomet comprehensive reverse total shoulder system. This biomodular shoulder surgical technique is utilized by david m. The comprehensive segmental revision system offers modular. Request pdf the biomet comprehensive reverse total shoulder system. Infraspinatus and teres minor you should feel this exercise at the back of your shoulder and into your upper back equipment needed. As a result of the failure, additional surgery is needed to remove and replace the allegedly defective devices.
Biomet, as the manufacturer of this device, does not practice medicine and does not recommend this device or technique. Mar 03, 2017 if you have a comprehensive reverse shoulder implant, these are the three steps that you should take. Hcp content posted july 12, 2016 in animated demonstrations and zimmer biomet extremities. Aug 25, 2008 class 1 recall issued for the zimmer biomet comprehensive reverse shoulder recalled by the fda due to serious device fractures. Zimmer biomet comprehensive shoulder implant lawsuit claims. For zimmer biomet sales representatives, you can log in to access more information 3d preoperative planning and intraoperative instrument guides to assist surgeons in the precise alignment of knee implants, tailored to the patients unique anatomy. The comprehensive reverse shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to.
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. Each surgeon is responsible for determining the appropriate device and technique to utilize on each individual patient. Biomet comprehensive reverse shoulder products are indicated for use in patients whose shoulder. The zimmer biomet comprehensive reverse shoulder is a device that is surgically implanted to help patients restore arm movement. In february of 2016, biomet agreed to settle a case, filed in a denver federal court, in which a patient claimed that he had suffered implant fractures with two separate comprehensive reverse shoulder devices. Product liability lawsuits are currently being filed against zimmer biomet alleging that the comprehensive reverse shoulder systems failed.
Utilizing innovative technologies, the system is able to allow for surgeon efficiency through. Biomet as a manufacturer of this device does not practice medicine and does not recommend this device or. Zimmer biomet is recalling the comprehensive reverse shoulder because these devices are fracturing at a higher rate than is stated in the labeling. After you calibrate your image and select a merge healthcare implant overlay, the application automatically scales the im plant overlay to the true image size based on the image calibration. Comprehensive reverse shoulder system the comprehensive reverse shoulder builds on the foundation of the comprehensive shoulder system. Positioning sleeve selection select the proper sized positioning sleeve based on the size of the tap used in step 3. In the recall notice, zimmer biomet said its comprehensive reverse shoulder system. The biomet comprehensive reverse shoulder arthroplasty rsa is newer. Zimmer biomet reverse shoulder lawsuits what you must know. Approximately 55 percent of all shoulder replacements are the result of complex fractures of the proximal humerus. In both cases, the patient did not comply with the warnings in the package insert. Zimmer biomet recalls comprehensive reverse shoulder replacement.
For product information, including indications, contraindications, warnings, precautions and potential adverse effects, see the package insert and biomets website. 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. Zbh comprehensive reverse shoulder system over issues with the devices fracturing. Zimmer biomet comprehensive reverse shoulder system is being recalled because of high fracture rate. I had to solve a similar problem and what i ended up doing was creating a small pdfmerge utility that uses the pdfsharp project which is essentially mit licensed the code is dead simple, i needed a cmdline utility so i have more code dedicated to parsing the arguments than i do for the pdf merging. The implant is designed to enable surgeons to repair broken bone while replacing the damaged shoulder joint. Biomet claims first with shoulder system orthopedics this week. This was accomplished by combining the baseplate and modular central screw with biomets exclusive versadial glenosphere. The comprehensive humeral positioning sleeves are for cemented use only and are intended for use with the comprehensive fracture stem. The agency designated the zimmer biomet shoulder replacement recall class i, which indicates that the affected devices could cause serious injury or death. Comprehensive total shoulder system surgical technique. Step 5 insertion of the positioning sleeve utilize the proper sized inserter for the chosen.
Ensure both xrays are at the same degree of external rotation. Make a longitudinal incision through the tendinous portion of the subscapularis muscle and capsule, just medial to the lesser tuberosity figure 3. The comprehensive total shoulder system is an evolutionary design based on the successful clinical heritage of the biomodular shoulder system. Zimmer biomet reverse shoulder lawsuit lawyer settlements. Cementless surface replacement arthroplasty of the shoulder. Zimmer biomet shoulder replacement recall for comprehensive. Comprehensive reverse shoulder system zimmer biomet tv. In cases of severe contracture, subscapularis lengthening. Zimmer biomet s comprehensive total shoulder system design is based on the successful clinical heritage of the biomodular shoulder system.
The comprehensive shoulder system zimmer biomet summit surgical. Zimmer biomet reverse shoulder recall lawsuit lawyer. The letter identifed the affected product, problem and actions to be taken. The system uses innovative technologies to allow intraoperative flexibility, unmatched humeral stem options, and infinite humeral head offset possibilities. Associated component involved comprehensive shoulder stem b 4. Orthopaedic automatic hip templating with the merge orthotemplates and imagesnap technology, merge healthcare introduces. 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 segmental revision system zimmer biomet.
The anatomical shoulder cemented, uncemented pressfit, fracture and revision humeral stems are compatible with the ashcom shoulder acconnector and the comprehensive reverse trays and bearings. Request pdf the biomet comprehensive reverse total shoulder system design considerations and surgical techniques the biomet comprehensive reverse shoulder arthroplasty rsa is newer. Class 3 device recall biomet comprehensive shoulder system. Three steps that all patients of the zimmer biomet. Biomet comprehensive srsdiscovery elbow ulna components. Biomet has received two complaints of this problem. 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. Comprehensive total shoulder system figure 3 patient positioning and incision identify anterior structures and externally rotate the humerus.
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