Exactech Shoulder, Hip, Knee, & Ankle Devices
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Minneapolis Exactech Recall Injury Attorneys
January 2024 FDA Warning: Exactech Shoulder Replacements At Risk of Device Failure
On January 16, 2024, the Food and Drug Administration warned patients and healthcare providers that Exactech shoulder replacements implanted between 2004 and 2021 may be prone to cracking, fracture, and device failure. The agency warned that the Exactech Equinoxe Shoulder Systems were packaged in defective storage bags that exposed the devices to excessive oxygen. Exposure of the shoulder replacement devices to oxygen causes a chemical reaction called oxidation, which can weaken components made of plastic over time.
If you or a loved one has been implanted with an Exactech Equinoxe Shoulder System and is experiencing pain or required a revision surgery due to device failure, contact Goldenberg Lauricella today for a free consultation. We have over 38 years of experience representing patients injured by defective medical devices such as the Exactech Equinoxe Shoulder System.
The FDA warned that patients who had the Exactech Equinoxe Shoulder System implanted between 2004 and 2021 may be at risk of device failure and revision surgery. Symptoms of Exactech shoulder device failure include:
- New or worsening pain
- Bone loss
- Swelling
- Grinding or other noise in shoulder
- Inability to use arm
- Device cracking
- Device fracture
- Weakness around shoulder device
Any of the symptoms above may indicate shoulder device failure and could necessitate a revision surgery to remove and replace the failed device. The FDA recommends that any patients who are experiencing pain in their Exactech shoulder replacement device should contact their health provider to discuss treatment options. As of January 18, 2024, Exactech had refused to recall the Equinoxe Shoulder Systems.
Goldenberg Lauricella is currently representing patients who have had other Exactech devices fail due to oxidation. We have the expertise you need to pursue a case for your defective shoulder replacement device. Contact our Minneapolis personal injury lawyers today at 1-800-903-1643 for a free Exactech shoulder replacement lawsuit consultation.
Exactech Recall Lawsuits
Goldenberg Lauricella is investigating Exactech recall cases involving shoulder, hip, knee, and ankle device failure. Between June 2021 and August 2022, Exactech recalled thousands of hip, knee, and ankle devices due to a defect that causes the devices to to prematurely weaken and fail. Device failure is painful and often leads to revision surgery. The recalled devices were implanted between 2004 and 2021.
The defect is due to defective packaging that exposed the plastic components in the devices to excessive oxidation. In other words, the bags that the devices were stored in allowed too much oxygen to contact the plastic components of the device before implant. This oxidation weakened the components before they were ever implanted into patients and has led to device weakening, bone loss, device failure, and revision surgery.
Please call (800) 903-1643 today for a free Minnesota Exactech Recall lawsuit consultation.
Injuries Associated with The Exactech Hip, Knee, and Ankle Recalls
Injuries related to the Exactech device defect include:
- Revision Surgery
- Bone Loss
- Loosening
- Swelling
- Instability
- Pain
Exactech Hip Replacement Recalls
In June 2021, Exactech recalled acetabular liners for its Novation, Acumatch, and MSC hip replacement devices due to premature weakening and failure. At the time, the company said it did not have an explanation for the premature wear but was investigating the cause. Exactech later discovered that its devices were weakened prior to implant due to excessive exposure to oxygen in defective storage bags. Exactech expended its hip replacement recalls in August 2022 to include all hip devices with plastic liners that were stored in the defective bags dating back to 2004. A letter informing patients of the device defect and recall was sent in July 2022. The letter includes the diagram below of its hip replacement device. The plastic acetabular liner is the component weakened by oxidation in the defective storage bags.
Exactech Hip Diagram Included In Its Letter to Patients.
If you have undergone a revision surgery due to a recalled Exactech hip replacement device, you may be eligible to file an Exactech hip replacement lawsuit. Contact the Minnesota Exactech Hip Replacement Lawyers at Goldenberg Lauricella for a free consultation today.
Exactech Knee Replacement Recalls
In February 2022, Exactech expanded its recall of all Optetrak, Logic, and Truliant knee replacement devices due excess oxygen exposure in storage bags. The company estimated that at least 80 percent of its knee devices manufactured since 2004 had been packaged in the defective bags that exposed the plastic components on its devices to oxygen. This oxidation weakened the devices before they were even implanted in patients. The company identified even more devices in April 2022 when it issued an Urgent Medical Device Correction notice advising health care providers to stop implanting devices that were stored in the defective bags.
According to Exactech’s Knee and Ankle Recall FAQ, the devices with components packaged in the defective bags may be associated with the following risks:
1. Statistically significant higher and earlier than expected revision rates in Optetrak Total Knee Replacement (TKR)
2. Increased risk of polyethylene (plastic) wear, and
3. Potential development of osteolysis (bone loss) in the first-generation Optetrak TKR
4. The reasons for revision potentially associated with polyethylene wear (e.g., loosening, lysis, pain) were increased three- to seven-fold in the Optetrak TKR when compared to other TKRs, and may be related to the non-conforming packaging.
The Minneapolis Knee Replacement Attorneys at Goldenberg Lauricella have successfully handled many defective knee replacement lawsuits in our 37 years of experience. We have the expertise you need to litigate your case against a large corporation like Exactech. Call us at 1-800-903-1643 today for a free Exactech knee replacement lawsuit consultation.
Exactech Ankle Replacement Recall
On February 7, 2022, Exactech issued a recall of all Vantage total ankle replacements that had been packaged in defective bags. Like the hip and knee replacement recalls, the plastic liners of the ankle replacement devices were exposed to excessive oxygen prior to being implanted. This left the plastic liners on many devices vulnerable to early weakening and failure, often leading to severe pain and revision surgery.
Goldenberg Lauricella, PLLC Can Help
The Minnesota Exactech Recall Lawyers at Goldenberg Lauricella have the expertise you need to be successful with your case. We have evaluated thousands of defective hip, knee, and ankle cases throughout our 38 years of experience and we know what a winning case looks like.
Free Consultations. If you had to undergo a shoulder, hip, knee, or ankle revision surgery due to the failure of a recalled Exactech device, contact our team today at (800) 903-1643 for a free consultation. Leave the sleepless nights to us.
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