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August 11, 2022. Exactech expands hip recall, adding 40,000 more hip implants to its hip replacement recall in the U.S. The company admits to packaging problems that can cause the plastic hip liners to oxidize and wear out much sooner than expected.
The latest recalled Exactech implants include:
Exactech hip implant failures related to the polyethylene parts in the implants may result in patients having to undergo complex hip revision surgery to remove and replace the defective Exactech hip liners.
In a second recall for Exactech hip liners in less than a year, this August recall admits to packaging problems and poor manufacturing techniques as the reason for recalling a total of almost 130,000 hip replacements used between 2004 and 2022.
The August 11, 2022, letter, states: “GXL inserts manufactured since 2004 were packaged in out-of-specification (referred to hereafter as “non-conforming”) vacuum bags that are oxygen resistant but do not contain a secondary oxygen barrier layer known as ethylene vinyl alcohol (EVOH), which further augments oxygen resistance.”
This means that the vacuum bags wrapping around the hip liner should have two oxygen layers, whereas, the recalled hip implants only had one layer of protection. This allows oxygen to seep into the bags, which can severely corrode the plastic hip inserts.
Exactech’s hip liners for the recalled devices are failing at a high rate and much earlier than its intended lifespan. Models that Exactech makes are part of a metal-on-polyethylene (MOP), or metal-on-plastic, hip implant. Most MOP replacements can last 25 years or more.
Make a follow-up appointment with your surgeon, especially if you have not seen him or her in the past 12 months. Routine exams are important whether or not you have symptoms of premature failure. They can help monitor your health when you have a hip implant.
Contact an attorney who can help you preserve evidence in case you have a claim. You should be aware that there is a limited amount of time to file a claim for injuries from a defective Exactech hip replacement.
We advise against giving your information to Exactech. Exactech has said they will cover your out-of-pocket medical costs; however, you should know that signing up or agreeing to any type of compensation from Exactech may mean you are signing your rights away. The best advice is to contact an attorney at Nash & Franciskato BEFORE contacting the Exactech-Broadspire Helpline. Even looking up your hip replacement serial number on the Exactech recall website may impact your rights so contact us first.
Early wear can cause complications such as joint loosening, tissue and muscle damage, and weakening or loosening of the hip implant.
Symptoms of implant failure include:
Plastic debris from poly wear can cause an adverse reaction called osteolysis, or bone degeneration. Osteolysis causes bone to deteriorate making revision surgery and rehabilitation more difficult. It also can leave patients with a permanent disability.
Contact your doctor immediately if you are experiencing any symptoms.
Don’t wait to get help because it could hurt your case.
Do you Need Revision Surgery?
Revision surgery is more complicated than the original hip replacement since it involves removing the defective implant. The surgeon may have to repair tissue, muscle, and bone damage from the first device. Contact your surgeon to schedule a follow-up appointment.
Exactech, a Gainseville, Florida medical device manufacturer, has already recalled over 90,000 hips, 140,000 knees and around 2,500 ankles, all related to a failure of the polyethylene parts in the implants.
The first hip recall, June 28, 2021, the company reported a high failure rate on its hip implants citing the cause as surgeon technique or patient specific factors.
On October 4, 2021, Exactech began recalling polyethylene liners in knee and ankle implants manufactured in 2004 or later. In February 2022, the recall was expanded to include all knee and ankle arthroplasty polyethylene inserts packaged in non-conforming bags regardless of label or shelf life.
Companies like Exactech that manufacture medical products have a responsibility to make their products reasonably safe in their design, manufacture, and packaging and should be held responsible when there is a problem.
Patients face an increased risk of hip replacement failure, complications caused by the defective plastic insert along with unnecessary medical bills, and pain and suffering.
Find out if you have a case against Exactech.
Have you been advised to undergo a revision surgery, or have already had one, due to complications associated with one of Exactech’s knee, ankle or hip replacement devices? Maybe you just want to find out your options. Contact the law offices of Nash & Franciskato at (877) 284-6600. The time to request your free, no-obligation case review is now. We will review your case in a confidential consultation, with no risk or obligation to take legal action
It can be devastating when the medical devices you rely on fail. The Nash & Franciskato Law Firm has a proven track record against medical device manufacturers.
Call us today at (877) 284-6600. One of our experienced staff will speak with you personally and will provide you with a free, no-obligation review of your case.
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