Fda class i recall issued for zimmer biomet reverse. For product information, including indications, contraindications, warnings, precautions and potential adverse effects, see the package insert and biomet s website. Zimmer biomet comprehensive reverse shoulder implant. Zimmer biomet recall of comprehensive reverse shoulder. 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. Biomet manufactures a variety of shoulder joint replacement prostheses intended for partial or total shoulder joint arthroplasty for use in cemented and uncemented biological. As a result of the failure, additional surgery is needed to remove and replace the allegedly defective devices. In december 2016, zimmer biomet issued an fsn informing clinicians of the higher than anticipated rate of fracture of titanium comprehensive reverse.
The implant is designed to enable surgeons to repair broken bone while replacing the damaged shoulder joint. The comprehensive total shoulder system is an evolutionary design based on the successful clinical heritage of the biomodular shoulder system. 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. Instead of improving arm movement, however, the implant caused several problems and, on december 20, 2016.
Shoulder replacement prostheses are indicated for use. Zimmer biomet recalls comprehensive reverse shoulder due. Biomet comprehensive shoulder implant lawsuit claims. These results support the surface cement technique with a modular gritblasted titanium surface and cruciform stem during primary tka. In september 2010, biomet recalled about 45 of the comprehensive reverse shoulders due to fractures between the trunnion and baseplate. Zimmer biomet recalls comprehensive reverse shoulder due to a. The science and art of medical care is to provide the right. Victims of such fractures may be entitled to file a zimmer biomet shoulder replacement lawsuit to obtain compensation for damages incurred as a result of their injury. Product liability lawsuits are currently being filed against zimmer biomet alleging that the comprehensive reverse shoulder systems failed.
The thumb screw on the resection boom is not captured. Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due. Shortly after zimmer biomet announced the recall of certain comprehensive reverse shoulder humeral trays in late 2016, attorneys around the country began airing tv commercial to ensure that affected patients were aware of their important legal rights. 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. The comprehensive shoulder stems fracture, primary. Keeping your shoulder and elbow level, slowly raise your hand until it is in line with your head. Titanium glenospheres are intended for patients with cobalt alloy material sensitivity. The baseplate and modular bicortical central screw allow the utilization of the best bone available within the glenoid. The comprehensive shoulder system shoulder education. Over 1 million times per year, biomet helps one surgeon. Ensure both xrays are at the same degree of external rotation. All books are in clear copy here, and all files are secure so dont worry about it. According to a medical device recall issued in february by the fda.
Radiographs were evaluated by one of the authors according to the knee society total knee arthroplasty roentgenographic evaluation and scoring system 27 for radiolucent zones, femoral component flexion and valgus, tibial component slope and kne, and anatomic axis was measured on the longstanding film for overall mechanical alignment. Mar 02, 2019 zimmer biomet offers surgeons knee replacement solutions, with a comprehensive suite of orthopaedic knee implant products and instruments. The zimmer biomet comprehensive reverse shoulder system is a surgicallyimplanted artificial shoulder device used to help restore arm movement in patients with rotator cuff tears who have developed a severe type of shoulder arthritis called arthropathy, and for whom traditional shoulder replacement is not an option. 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 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. Total shoulder system is an evolutionary design based on the successful clinical heritage of the biomodular. Accuracy of patientspecific instrumentation in shoulder arthroplasty. Aug 25, 2008 zimmer biomet is recalling the comprehensive reverse shoulder because these devices are fracturing at a higher rate than is stated in the labeling.
The upper part of the operating table has to be open on the homolateral side to allow shoulder extension shoulder table. Zimmer biomet has issued three recalls of the comprehensive reverse shoulder implant, due to risks of fracture or defective locking rings. The comprehensive fracture, and revision and micro. Read online surgical technique zimmer biomet book pdf free download link book now. 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 biomet has announced a recall for certain comprehensive reverse shoulder products due to a higherthan expected risk of fracture. Jul 12, 2016 comprehensive reverse shoulder system. With the baseplate in position, the versadialglenosphere allows the ability to select both the amount and direction of offset.
Biomet shoulder replacement class action lawsuit biomet. The arcos platform comprehensive solutions that simplify the complex. Determine amount of comminution and proximal bone loss on xray andor ct scans. Zimmer biomet comprehensive shoulder implant lawsuit claims. Comprehensive total shoulder system surgical technique. Zimmer biomet is being sued because its reverse shoulder implant has been failing at a rate higher than the company initially revealed. Class 3 device recall biomet comprehensive shoulder system. 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. Biomet, as a manufacturer of this device, does not practice. Mar 08, 2017 the fda recently issued a class i recall for the zimmer biomet comprehensive reverse shoulder system humeral tray model 115340. Hcp content posted july 12, 2016 in animated demonstrations and zimmer biomet extremities. Biomet comprehensive reverse shoulder arthroplasty rsa is the result of the combination of the biomet comprehensive shoulder system. Biomet claims first with shoulder system orthopedics. Comprehensive total shoulder system figure 12 figure set the correct version using the amount of external rotation of the forearm, slide the resection guide against the humerus and finger tighten the thumb screw.
The company says this is the only device of its type that features a patentpending dual trajectory, allowing surgeons to elect a reverse or total shoulder procedure intraoperatively. Comprehensive reverse titanium shoulder tray specific. Surgical technique zimmer biomet pdf book manual free. Sixty patients 65 knees died prior to a fiveyear followup and had not undergone revision tka at the last followup.
Set the correct version using the amount of external rotation of the forearm, slide the resection. 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. Comprehensive reverse shoulder system zimmer biomet. Fractures may result in revision surgeries which could cause serious adverse health consequences such as permanent loss of shoulder function, infection, or rarely, death. Jul 30, 2019 zimmer biomet offers surgeons knee replacement solutions, with a comprehensive suite of orthopaedic knee implant products and instruments. The fda this week released information on a class 1 recall of zimmer biomets nyse. The comprehensive shoulder system was developed in conjunction with david dines, m. Zbh comprehensive reverse shoulder system over issues with the. The position of the resection guide boom on the reamer shaft, along with the calibrated reaming depth and stem choice, are directly related. 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. Biomet comprehensive reverse shoulder products are indicated for use in patients whose shoulder. In both cases, the patient did not comply with the warnings in. Zimmer biomet is recalling the comprehensive reverse shoulder because these devices are fracturing at a higher rate than is stated in the labeling.
The implants are designed to create a new, smoothly functioning joint that can prevent painful boneonbone contact. Fda class i recall issued for zimmer biomet reverse shoulder. Comprehensive shoulder system, 4 mm, 122 mm long, primary shoulder stem, ti6al4v, standard length porous plasma. Request pdf the biomet comprehensive reverse total shoulder system design considerations and surgical techniques the biomet comprehensive reverse shoulder arthroplasty rsa is newer. Zimmer biomet shoulder replacement lawsuit for fracture. The cause of the bending fatigue could not be determined. The versadial humeral head prosthesis is intended for use only with the comprehensive humeral fracture stem and the glenoid components of the biomodular shoulder system. Yom firms zimmer biomet environmentally controlled room specifications standard operating procedme, sop 9. Zimmer biomet shoulder replacement recall commercial. Shoulder, elbow, and wrist replacement implants use metal alloys and polyethylene plastic to restore motion and reduce or eliminate pain. 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 segmental revision total and reverse. Comprehensive fracture system preoperative planning evaluate xrays of both the fractured shoulder and the contralateral shoulder. Those with rotator cuff tears or severe shoulder arthritis were some of the intended patients for this device.
Zimmer comprehensive reverse total shoulder system zimmer biomet. The latest generation of biomet comprehensive reverse shoulder system biomet, warsaw, indiana is. In addition to those specified above, the proximal. Biomet comprehensive reverse shoulder products are intended for total. The comprehensive reverse shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due. Five patients with a total of six humeral traytaper failures were identified from 300 patients with. Zimmer biomet reverse shoulder lawsuit lawyer settlements. The comprehensive humeral fracture stem is intended for use with the biomodular humeral heads and glenoid components. Zbh comprehensive reverse shoulder system over issues with the devices fracturing. Associated component involved comprehensive shoulder stem b 4. Extend involved shoulder over the edge of the table so the arm can be brought into full extension and adduction. Zimmer biomet reverse shoulder recall lawsuit lawyer. Biomet has received two complaints of this problem.
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. The comprehensive srs system is compatible with comprehensive shoulder. Zimmer biomet reverse shoulder lawsuits what you must know. This site is like a library, you could find million book here by using search box in the header. The fda recently issued a class i recall for the zimmer biomet comprehensive reverse shoulder system humeral tray model 115340. For product information, including indications, contraindications, warnings, precautions and potential adverse effects, see the package insert and biomets website. The zimmer biomet comprehensive reverse shoulder is a device that is surgically implanted to help patients restore arm movement.
The fda has announced a class i recall for the zimmer biomet comprehensive reverse shoulder after the device was linked to high rates of fracture, which could require revision surgery leading to adverse health complications free confidential lawsuit evaluation. On september 4, 20, biomet orthopedics, llc, announced the first clinical use in the u. 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. Ischs opinionsincluding as to biomets regulatory compliance and the adequacy of biomets design, manufacturing, and distribution of the comprehensive reverse shoulder systemwould. 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 choice of implant was comprehensive reverse shoulder system biomet inc.
Shoulder joint replacement components include humeral stems, humeral heads, and glenoid components. In addition to those specified above, the proximal shoulder replacement prostheses are indicated for use in oncology applications, complex humeral fractures and revisions. 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. Utilizing innovative technologies, the system is able to allow for surgeon efficiency through. Comprehensive reverse shoulder system the comprehensive reverse shoulder builds on the foundation of the comprehensive shoulder system. Product liability lawsuits are currently being filed against zimmerbiomet alleging that the comprehensive reverse shoulder systems failed. Fractured devices can require painful removal surgery, as well as infection, permanent loss of shoulder function, or death. Clinical outcomes and complications of cementless reverse total. Zimmer biomet shoulder lawsuits consumer safety watch. Zimmer biomet comprehensive reverse shoulder system is being recalled because of high fracture rate on february 16, 2017, the u. Biomet also makes mini and micro stem versions of the humeral components for the comprehensive shoulder system. Plaintiff also argues that biomet was required to tender a complete expert report pursuant to fed.
These options provide intraoperative flexibility, even in complex revision cases. If you or a loved one had problems after shoulder replacement surgery, you should contact our law firm immediately. Comprehensive nano stemless shoulder zimmer biomet. 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 offers surgeons knee replacement solutions, with a comprehensive suite of orthopaedic knee implant products and instruments.
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