In February of this year, surgeons across the country received a draft of a recall letter from Exactech that addressed problems with certain knee and ankle implants. According to the letter, one of the packaging layers for the polyethylene plastic insert did not conform to specifications. These non-conforming bags should have contained an additional barrier layer of ethylene-vinyl alcohol (EVOH), which provides oxygen resistance for the implant. When oxygen is allowed to permeate the plastic inserts, it can cause oxidation during storage or before the joint replacement surgery. This could cause the implants to fail much earlier than expected and puts patients at risk for a range of health complications, including the need for revision surgery.
If you have received a recalled Exactech knee, ankle, or hip implant, you are urged to contact a highly skilled lawyer at your earliest convenience.
All medical device manufacturers have a legal obligation to ensure that their products are safe. If a medical product is defective or fails to deliver the intended benefits, the company has a responsibility to issue a recall.
Exactech specializes in surgical implant systems that are used in joint replacement surgeries. In 2021, the company announced a recall of all of its knee and ankle arthroplasty polyethylene inserts, which had been used since 2004 in roughly 140,000 knee and ankle replacement surgeries. In February of 2022, Exactech stated that their ankle and knee replacements are prone to defects and that patients experienced a high rate of failure. This prompted a sweeping recall of their ankle and knee replacement systems after it was discovered that the defective plastic insert caused them to oxidate and fail prematurely. However, the company did not make any effort to contact patients who received one of the defective medical products. They created a template recall letter and sent it to surgeons, who were asked to notify their patients who were impacted by the recall.
Exactech initially recalled a limited number of its knee and ankle arthroplasty polyethylene inserts in August of 2021. However, the company has expanded its recalls to include all polyethylene inserts shipped with knee and ankle implants in non-conforming bags. This includes certain knee, ankle, and hip implants.
According to the recall, patients may experience the following side effects from the defective hip, knee, or ankle implants:
Unfortunately, these are serious complications that often require revision surgery to fix. While all surgical procedures come with a certain degree of risk, revision surgery has a greater risk of complications than the initial surgery because it often takes longer and is more complicated. In addition, patients may experience the following complications following revision surgery:
Even if revision surgery is not needed, surgeons are strongly urged to closely monitor their patients for the risk of premature wear and tear, osteolysis, or knee failure. If there are signs that the implant has failed, the doctor will most likely recommend revision surgery.
The recall letter instructs surgeons to stop using the implants in all knee and ankle replacement surgeries. In addition, doctors and hospitals have been instructed to return all existing inventory to the manufacturer. Patients who have already undergone knee or ankle replacement surgery may receive a letter from their doctor notifying them of the recall. Doctors are urged to keep detailed records of all patients with Exactech implants and closely monitor them for signs of insert failure. If you have not received a letter and you are experiencing any side effects, you should consult with your health care provider immediately.
If you suffered a serious injury or health complication from a recalled Exactech implant, you may be eligible for the following damages:
Currently, there are no reported settlements in any Exactech implant lawsuits. However, an experienced lawyer can review other defective implant cases and compare the details of your case to those cases.
In response to the recall, Exactech has set up a claims process to reimburse patients who have been impacted by the defective implant. However, by using the Exactech claims process, it could prevent you from collecting the maximum amount of financial compensation that is possible. In addition, it is important that you understand that patients who file a claim with Exactech may waive their right to file a medical products liability lawsuit against the company. It is highly recommended that you avoid this route and contact a lawyer.
If you are experiencing side effects from the recalled Exactech implant, you are urged to contact one of our Philadelphia defective medical device lawyers at Brookman, Rosenberg, Brown & Sandler as soon as possible. Call us at 215-569-4000 or contact us online to schedule a free consultation. Located in Philadelphia, we serve clients throughout New Jersey and Pennsylvania, including Delaware County, Chester County, and Philadelphia County.