Hundreds of thousands of hip replacement procedures are performed each year in the United States, with many of these procedures requiring the need for a subsequent “revision” procedure. Because of the substantial number of hip replacement procedures performed each year, patients who have had hip replacement procedures should have a […]

A U.S. Food & Drug Administration (FDA)-prompted Class 1 recall one year ago led an Ireland-based company to stop manufacturing and marketing its cancer-causing, textured breast implants and tissue expanders. The recall, the most serious type issued by the agency, followed an FDA analysis that concluded the implants made by […]

The U.S. Food and Drug Administration has issued a Class 1 recall for a handheld instrument used during hip-replacement surgery. The device failed sterility tests. Greatbatch Medical Recalls The Affected Instrument Greatbatch Medical recalled the instrument, a Standard Offset Cup Impactor. The instrument enables doctors to implant cups and balls […]

In December 2016 Zimmer issued a Class one recall of its Comprehensive Reverse Shoulder Implant System Humeral Tray. Zimmer received 510(K) clearance to market this device in 2008. According to the FDA’s Recall Database, approximately 300 lots of the shoulder implant are being recalled because of a higher than anticipated […]

Debra Kilmer filed suit against Stryker Corporation, Stryker Sales Corporation and Howmedica Osteonics Corporation (“Defendants”), asserting that she had been injured by a defective knee implanted in her in Florida state court. Defendants removed the action to the United States District Court for the Middle District of Florida citing diversity […]

Johnson & Johnson (“J&J”) has reached a four million dollar settlement with the state of Oregon to resolve allegations that J&J improperly marketed its DePuy ASR metal-on-metal hip implants.  J&J has recalled 93,000 ASR hip implants, which had a 12% failure rate in five years. David Hart, Oregon’s Assistant Attorney General […]

It really doesn’t sound like a question we need to be asking because it should be a matter of common sense. Shouldn’t any medical device that is permanently implanted in the human body be put through a high degree of scrutiny for safety and efficacy so we don’t have to test it […]

The American Academy of Orthopaedic Surgeons (AAOS) recently published an “information statement” for patients who have been affected by the recent metal-on-metal (MoM) hip disaster. The statement is not a rigorous academic analysis of the current situation with MoM hips, but it does provide a fantastic resource for patients who […]

Two separate medical cases, published in leading medical journals the same week, highlight mysterious symptoms that were eventually attributed to metal poisoning from a metal-on-metal (MoM) hip prosthesis. A paper published February 8, in the British medical journal, The Lancet, described a German patient’s quest for an accurate diagnosis. His […]

It is no surprise that the government of the United Kingdom has taken a move to ban metal hips made by leading medical device manufacturers. The government funds surgeries at its National Health Service Hospitals (NHS) and was tired of the high failure rates and costs associated with early revision […]