FDA Investigates Metal Poisoning from Zimmer Hip Replacements

As concerns grow about the levels of cobalt and chromium shed by metal on metal hip replacement devices, the FDA is ordering manufacturers to conduct followup research on patients to see what health effects the implants may have. In all, FDA sent a total of 145 post marketing surveillance orders to 21 different manufacturers including Zimmer. When completed, the studies will include information about the level at which the metal particles shed by hip replacements becomes dangerous, how much metal the devices actually shed, and what the potential side effects are. It is known that over time, metal particles around some implants can lead to damage to bone and/or tissue around the implant or joint. This damage is referred to by some as an "adverse local tissue reaction (ALTR)" or an "adverse reaction to metal debris (ARMD)." Many patients are experiencing Zimmer hip implant failure and need a revision surgery.

Zimmer Hip Lawsuit Settlements On the Horizon

As a result of the ongoing Zimmer hip lawsuits filed by patients who have experienced side effects as a result of Zimmer hip replacement systems, several settlements have been given out, amounts that could help compensate for costs associated with the hip replacement complications. Medical bills, lost wages, and other expenses will be considered when a settlement is given out.
After a series of lawsuits aimed at the orthopedics manufacturing giant Zimmer surfaced over their metal-on-metal hip replacement systems, Zimmer set aside an amount of $47.5 million in order to cover settlements and jury verdicts surrounding the case. Recently this amount has grown to nearly $145 million, proving that Zimmer is prepared to hand out a significant number of settlements.

Zimmer Places Blame On Doctors for Hip Failures

Since August 19, 2008, Zimmer has been offering web-based training to surgeons to highlight important aspects of the Durom Cup design, pre-operative planning that is necessary and detailed instructions on special surgical techniques that are required. They have indicated that they will start making the Zimmer Durom Hip Cup available to doctors after they complete the internet training. Zimmer allowed approximately 12,000 people in the United States to receive their Durom Cup, even though they knew or should have known that doctors were not provided with adequate warnings and instructions about the surgical techniques required to avoid failure of the hip replacement parts. According to Zimmer’s own estimates, some doctors experienced Zimmer hip implant failure rates as high as 5.7% with the Durom Cup.

Zimmer Hip Failures May Also Be Causing Metal Poisoning

  Metal-on-metal hip replacements, which use cobalt and chromium in their construction, currently account for about one-third of the 250,000 hip replacements performed each year in the United States. However, in recent years, concerns over problems with metal-on-metal hip replacements have been growing. Many metal-on-metal hip replacements have been linked to a high rate of early failure. This is the main focus of what is becoming known as the Zimmer hip lawsuit. Surgeons and doctors were choosing the Zimmer Dorum for patients that, under normal conditions, would require a full hip replacement, especially considering that it was designed to be a long lasting solution. However, almost 12 percent of these patients needed surgery again within two years, caused major emotional and physical reaction.

Zimmer Hip Failure Affects Thousands

Before suspending sales of the Zimmer Durom Cup, Zimmer allowed approximately 12,000 people in the United States to receive their Durom Cup, even though they knew or should have known that doctors were provided with inadequate warnings and instructions about the surgical techniques required to avoid failure of the hip replacement parts. Zimmer’s own research data estimates that some doctors experienced Zimmer hip failure rates as high as 5.7%, though many estimate the numbers much higher. For months after doctors started reporting Zimmer Durom hip problems, Zimmer ignored safety concerns and refused to conduct a full investigation. According to current lawsuits, Zimmer has allowed thousands of people to be implanted with the Durom Cup without adequately disclosing the risks and necessary surgical techniques.

Zimmer Hip Lawyers Investigate

The FDA has received a large amount of reports stating that surgeons are performing revision surgeries on individuals with Zimmer hip implant failure. These reports have indicated that during the Durom Cup hip replacement revision surgery, surgeons observed the acetabular component of the Zimmer Durom Cup had loosened. Zimmer Durom acetabular cups, used for total hip replacements, had U. S. sales suspended until the firm revises surgical instructions and retrains physicians. The suspension is expected to cost the company between $20 million to $30 million, the company said. Zimmer stopped distributing Durom cups after the beginning of an investigation of its manufacturing process and more than 3,100 Durom Cup implant recipients. The investigation showed elevated incidents of cups loosening and an elevated revision surgery rate.

Zimmer Sets aside $150m for Settlements, 45 Lawsuits go into Mediation

Judge Susan Wigenton of the New Jersey federal court has ordered that 45 lawsuits brought against Zimmer Inc. should go forward into mediation. A third party mediator will be set up to distribute compensation due to side effects and failure of Zimmer’s Durom Cup, used in their hip replacements. $150 million has been set up by Zimmer to compensate the plaintiffs, many of whom suffered severe pain due to the breakdown of the Durom cup, in many cases, within 2-3 years of their initial surgery.