Which surgical implants were recalled
Biomet was a successful Indiana medical device company that was snapped up by Zimmer in 2014 for $13.4 billion. This new team, Zimmer Biomet, became the #2 producer of orthopedic implants in the country, only following DePuy Orthopaedics. As of 2016 they controlled 31% of the market and made $1.8 billion off their hip surgery implants that year.
Zimmer Biomet was the maker of a number of popular products, including primary/revision femoral and acetabular components. Their hip implants were made of a highly spongy, porous material that simulates bone, which encourages bone growth and stability.
These devices are surgically implanted into the pelvis so patients feel less pain and move more freely. They normally come in a variation of ceramic, plastic or metal. Biomet’s most troublesome device was a metal-on-metal hip replacement device called the M2a Magnum. Zimmer had its own problems with the Durom Cup.
The most significant issues were osteolysis (surrounding inflammation and loosening of an implant) and metallosis (shedding of metal particles that build up in soft tissue, which can result in blood poisoning). Because of how they were made and the materials used, the number of lawsuits surrounding these hip implant devices increased exponentially.
The company no longer uses metal-on-metal devices in hip replacement surgical implants. They have long been linked to complications. Theirs were made by forged metal; these were supposed to be sturdier and more durable. However, their cobalt chromium alloy metal, called Zimmer Metasul, ended up having the same issues as many other marketed metal-on-metal hip implant devices.
Zimmer Biomet lawsuits
Defective products lawsuits fall into one of three categories:
- Failure to warn: These are called “marketing defects” and focus on the supply chain. The product was designed as intended, but it did not have the correct warnings or instructions. This makes the product unreasonably dangerous to its end users.
- Manufacturing defect: Even if the product was designed to be safe, the end result was not. If that end product causes an injury to its intended user, the manufacturer can be held responsible.
- Design defects: Even if it was made as intended, that end product contains defects that can still endanger the user. A product can be unreasonably dangerous if it does not perform as expected when used it in its intended manner.
Metal-on-metal hip surgery implants such as the M2a Magnum or the Durom Cup would fall under “design defects.” They endangered the health and safety of the end user. Even when used as intended, they can shed particles that build up in soft tissue or loosen from the socket.
Nearly 13,000 patients received the Durom Cup hip surgery implant in the United States after the FDA approved it in 2006. Not even a year later, patients were experiencing issues and the device was briefly recalled. They put it back on the market with new surgical instructions, but that didn’t stop approximately 1,700 people from suing the company. They claimed that the Cup was a dangerous product and did not adequately warn of those potential problems.
The Durom Cup hip implant was recalled voluntarily in 2010 and removed from the market; the company learned that three out of every 10 hip implant devices failed (and, as lawsuits noted, still continued to market them). There is multidistrict litigation pending in New Jersey, which has been overseen by Judge Madeline Cox Arleo and had 700 cases pending. She ordered Zimmer to pay the plaintiffs’ court costs, which were substantial.
Zimmer’s corporate protocol is to attempt to settle cases before they can reach trial. As of 2010, they had set aside a fund of $145 million with which to settle cases and the number grew to their offer of $314 million for all Durom Cup hip surgery lawsuits in 2016. In May of that year, the court ordered that all plaintiffs in the MDL participate in the settlement.
However, plaintiffs could accept or reject the hip surgery settlement offer (about $175,000 per plaintiff, though those who had the Cup longer received less money), and 257 cases are still pending because of that. The deadline for scheduling mediation was February 28, 2017.
Meanwhile, there are no class-action lawsuits in the United States for Zimmer hip implant devices; however, there were three pending in Canada. They were closed as of September 5, 2017, and settlements ranged from $600 (that’s not a typo) to $40,000.
- Jones v. Zimmer GMBH, British Columbia, certified as a class-action case on September 2, 2011
- McSherry v. Zimmer GMBH, Ontario, certified as a class-action case on September 24, 2014
- Major v. Zimmer Inc., Quebec, certified as a class-action case on May 6, 2016
Recalls of Zimmer Biomet medical implant devices
Zimmer Biomet has voluntarily recalled multiple devices over the years (Biomet recalled 25; Zimmer recalled 104). Recalls can happen for many reasons, such as inadequate instructions, migration issues, early device failure, missing components and more. The following hip implant models have caused numerous problems:
- M2a, MDL (multidistrict litigation) #2391
- Zimmer Holdings
- Durom Cup (recalled temporarily in 2008, totally recalled in 2010, MDL #2158)
- Mayo Hip
- NexGen knee replacement, MDL #2272
- Persona Knee, lawsuits currently being filed as of January 2018
From 1999-2009 alone, more than 110,000 M2a devices were implanted into patients. It was actually one of Biomet’s most popular devices and was never officially recalled, despite its reported problems. As of 2017, there were still 466 cases pending.
What should I do if I think I have a defective Zimmer Biomet hip replacement implant?
If you’re not sure whether your Zimmer Biomet hip implant device is part of an active product recall, check with your surgeon. He will know what was implanted because it will be in your medical records. Then, search online to see if that hip surgery device corresponds to a recall. You can set up a Google alert for “Zimmer Biomet hip replacement recalls” and it will send you new results in the news. (How to set up a Google Alert.)
Watch your surgical site and visit your surgeon for a checkup at least annually. If there is pain, inflammation or other unusual symptoms, talk to your doctor immediately.
If you believe your device has failed or is failing, reach out to an attorney. You don’t want to file outside of the statute of limitations for your case. (This is the length of time in which you can file a claim, and it varies state by state.)
Check out the Enjuris law firm directory to find legal representation – you don’t have to represent yourself. (And you don’t want to – plaintiffs who represented themselves on a pro se basis received a 29% reduction in their settlement offers from Zimmer.)
- Hip Replacement Surgery
- DePuy Orthopaedics Hip Replacement Devices
- Hip Replacement Complications
- Hip Replacement Lawsuits
- Hip Replacement Surgery Overview
- Metallosis from Hip Replacement Devices
- OMNIlife Hip Replacement Lawsuits
- Recalls for Hip Replacement Devices
- Smith & Nephew Hip Replacement Devices
- Stryker Orthopedics Hip Replacement Recalls and Lawsuits
- Wright Medical Hip Replacement Devices
- Zimmer Biomet Hip Replacement Recalls and Lawsuits