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. Fractures may result in revision surgeries which could cause serious adverse health consequences such as permanent loss of shoulder function, infection, or rarely, death. Request pdf the biomet comprehensive reverse total shoulder system design considerations and surgical techniques the biomet comprehensive reverse shoulder arthroplasty rsa is newer. Instead of improving arm movement, however, the implant caused several problems and, on december 20, 2016. Product liability lawsuits are currently being filed against zimmerbiomet alleging that the comprehensive reverse shoulder systems failed. All books are in clear copy here, and all files are secure so dont worry about it. For product information, including indications, contraindications, warnings, precautions and potential adverse effects, see the package insert and biomet s website. Zbh comprehensive reverse shoulder system over issues with the devices fracturing. Titanium glenospheres are intended for patients with cobalt alloy material sensitivity.
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. Associated component involved comprehensive shoulder stem b 4. Determine amount of comminution and proximal bone loss on xray andor ct scans. Zimmer biomet recall of comprehensive reverse shoulder. The fda this week released information on a class 1 recall of zimmer biomets nyse. 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.
Hcp content posted july 12, 2016 in animated demonstrations and zimmer biomet extremities. Zimmer biomet shoulder replacement lawsuit for fracture. Zimmer biomet comprehensive reverse shoulder implant. 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. Class 3 device recall biomet comprehensive shoulder system. Comprehensive reverse titanium shoulder tray specific. The comprehensive total shoulder system is an evolutionary design based on the successful clinical heritage of the biomodular shoulder system. Set the correct version using the amount of external rotation of the forearm, slide the resection. 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.
Ensure both xrays are at the same degree of external rotation. Zimmer biomet reverse shoulder lawsuits what you must know. Biomet comprehensive shoulder implant lawsuit claims. 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. Jul 12, 2016 comprehensive reverse shoulder system. Fda class i recall issued for zimmer biomet reverse shoulder. Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due.
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 comprehensive reverse 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. These results support the surface cement technique with a modular gritblasted titanium surface and cruciform stem during primary tka. Total shoulder system is an evolutionary design based on the successful clinical heritage of the biomodular. Biomet comprehensive reverse shoulder arthroplasty rsa is the result of the combination of the biomet comprehensive shoulder system. Zimmer biomet recalls comprehensive reverse shoulder due. Shoulder replacement prostheses are indicated for use. Zimmer biomet has announced a recall for certain comprehensive reverse shoulder products due to a higherthan expected risk of fracture.
Biomet also makes mini and micro stem versions of the humeral components for the comprehensive shoulder system. The fda recently issued a class i recall for the zimmer biomet comprehensive reverse shoulder system humeral tray model 115340. Over 1 million times per year, biomet helps one surgeon. Comprehensive reverse shoulder system zimmer biomet. The science and art of medical care is to provide the right. Biomet comprehensive reverse shoulder products are indicated for use in patients whose shoulder. Zimmer comprehensive reverse total shoulder system zimmer biomet. The implant is designed to enable surgeons to repair broken bone while replacing the damaged shoulder joint. Zimmer biomet recalls comprehensive reverse shoulder due to a.
Zimmer biomet is recalling the comprehensive reverse shoulder because these devices are fracturing at a higher rate than is stated in the labeling. In december 2016, zimmer biomet issued an fsn informing clinicians of the higher than anticipated rate of fracture of titanium comprehensive reverse. This site is like a library, you could find million book here by using search box in the header. Biomet comprehensive reverse shoulder products are intended for total. As a result of the failure, additional surgery is needed to remove and replace the allegedly defective devices. Comprehensive segmental revision total and reverse. Mar 02, 2019 zimmer biomet offers surgeons knee replacement solutions, with a comprehensive suite of orthopaedic knee implant products and instruments. Fda class i recall issued for zimmer biomet reverse. Biomet manufactures a variety of shoulder joint replacement prostheses intended for partial or total shoulder joint arthroplasty for use in cemented and uncemented biological. 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. 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. Five patients with a total of six humeral traytaper failures were identified from 300 patients with. Plaintiff also argues that biomet was required to tender a complete expert report pursuant to fed.
Those with rotator cuff tears or severe shoulder arthritis were some of the intended patients for this device. 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. Surgical technique zimmer biomet pdf book manual free. 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. The choice of implant was comprehensive reverse shoulder system biomet inc. In addition to those specified above, the proximal shoulder replacement prostheses are indicated for use in oncology applications, complex humeral fractures and revisions. The arcos platform comprehensive solutions that simplify the complex. The thumb screw on the resection boom is not captured. Zimmer biomet is being sued because its reverse shoulder implant has been failing at a rate higher than the company initially revealed. Biomet shoulder replacement class action lawsuit biomet. 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. Zbh comprehensive reverse shoulder system over issues with the. Utilizing innovative technologies, the system is able to allow for surgeon efficiency through. Approximately 55 percent of all shoulder replacements are the result of complex fractures of the proximal humerus.
Biomet claims first with shoulder system orthopedics. 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. In september 2010, biomet recalled about 45 of the comprehensive reverse shoulders due to fractures between the trunnion and baseplate. Mar 08, 2017 the fda recently issued a class i recall for the zimmer biomet comprehensive reverse shoulder system humeral tray model 115340.
According to a medical device recall issued in february by the fda. The baseplate and modular bicortical central screw allow the utilization of the best bone available within the glenoid. In both cases, the patient did not comply with the warnings in the package insert. 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. Keeping your shoulder and elbow level, slowly raise your hand until it is in line with your head.
In both cases, the patient did not comply with the warnings in. Accuracy of patientspecific instrumentation in shoulder arthroplasty. The position of the resection guide boom on the reamer shaft, along with the calibrated reaming depth and stem choice, are directly related. Sixty patients 65 knees died prior to a fiveyear followup and had not undergone revision tka at the last followup. Jul 30, 2019 zimmer biomet offers surgeons knee replacement solutions, with a comprehensive suite of orthopaedic knee implant products and instruments. The comprehensive srs system is compatible with comprehensive shoulder.
Extend involved shoulder over the edge of the table so the arm can be brought into full extension and adduction. With the baseplate in position, the versadialglenosphere allows the ability to select both the amount and direction of offset. The comprehensive shoulder stems fracture, primary. Read online surgical technique zimmer biomet book pdf free download link book now. Zimmer biomet reverse shoulder lawsuit lawyer settlements. The latest generation of biomet comprehensive reverse shoulder system biomet, warsaw, indiana is. These options provide intraoperative flexibility, even in complex revision cases. The upper part of the operating table has to be open on the homolateral side to allow shoulder extension shoulder table. The zimmer biomet comprehensive reverse shoulder is a device that is surgically implanted to help patients restore arm movement. Zimmer biomet shoulder lawsuits consumer safety watch. The comprehensive humeral fracture stem is intended for use with the biomodular humeral heads and glenoid components.
Comprehensive fracture system preoperative planning evaluate xrays of both the fractured shoulder and the contralateral shoulder. The comprehensive shoulder system was developed in conjunction with david dines, m. Humeral traytaper failure in modular reverse total shoulder. The comprehensive fracture, and revision and micro. The cause of the bending fatigue could not be determined. On september 4, 20, biomet orthopedics, llc, announced the first clinical use in the u. Zimmer biomet has issued three recalls of the comprehensive reverse shoulder implant, due to risks of fracture or defective locking rings. Comprehensive reverse shoulder system zimmer biomet tv. Biomet, as a manufacturer of this device, does not practice. The implants are designed to create a new, smoothly functioning joint that can prevent painful boneonbone contact.
The biomet comprehensive reverse total shoulder system. 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 surgical technique. Comprehensive shoulder system, 4 mm, 122 mm long, primary shoulder stem, ti6al4v, standard length porous plasma. Product liability lawsuits are currently being filed against zimmer biomet alleging that the comprehensive reverse shoulder systems failed. 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. Zimmer biomet reverse shoulder recall lawsuit lawyer. 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. The comprehensive shoulder system shoulder education. 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. Comprehensive nano stemless shoulder zimmer biomet. Zimmer biomet shoulder replacement recall commercial. Zimmer biomet recalled certain biomet comprehensive reverse shoulder humeral trays in december 2016 due to the devices having a higher than anticipated fracture rate. Ischs opinionsincluding as to biomets regulatory compliance and the adequacy of biomets design, manufacturing, and distribution of the comprehensive reverse shoulder systemwould.
Biomet has received two complaints of this problem. Comprehensive reverse shoulder system the comprehensive reverse shoulder builds on the foundation of the comprehensive shoulder system. In addition to those specified above, the proximal. Zimmer biomet comprehensive reverse shoulder system is being recalled because of high fracture rate on february 16, 2017, the u.
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. Shoulder, elbow, and wrist replacement implants use metal alloys and polyethylene plastic to restore motion and reduce or eliminate pain. 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. 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. If you or a loved one had problems after shoulder replacement surgery, you should contact our law firm immediately.