Did You Suffer Injuries from an Exactech Implant?
Patients implanted with Exactech hip, knee, or ankle replacement devices that have since been recalled may be entitled to financial compensation for any injuries associated with the devices breaking down or failing prematurely, resulting in the need for revision surgery.
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Patients implanted with Exactech hip, knee, or ankle replacement devices that have since been recalled may be entitled to financial compensation for any injuries associated with the devices breaking down or failing prematurely, resulting in the need for revision surgery.
Thousands of hip, knee, and ankle implants manufactured by medical device maker Exactech, Inc. have been recalled due to a risk of premature failure the company says may be due to a packaging defect that caused the polyethylene insert components to degrade prior to implantation. According to Exactech, the degraded inserts may make affected hip, knee, and ankle replacement systems susceptible to premature failure, fracture, cracking, and other serious problems, in some cases just months after implantation. And in some cases, the complications may be severe enough that revision surgery is required to remove or replace the failed device. If you or a loved one received an Exactech implant and subsequently suffered side effects like implant fracture, pain, swelling, or bone loss, call our consumer advocates at Leading Justice today. You deserve to be compensated for the pain and suffering you have endured as a result of your failed Exachtech hip, knee, or ankle implant, and we can help you determine whether you may be eligible to file a claim against Exactech for financial compensation.
What Exactech Implants are Being Recalled?
Exactech’s medical device recalls and warnings have affected thousands of knee and ankle polyethylene inserts sold globally, as well as Exactech Connexion GXL and conventional polyethylene acetabular liners (hip implants) sold in the U.S. over the past decade. The following Exactech products are affected:
Knee and Ankle Replacements (manufactured since 2004):
- OPTETRAK® All-polyethylene Tibial Components (TKR)
- OPTETRAK® All-polyethylene Tibial Components (PKR)
- OPTETRAK® Tibial Inserts (TKR)
- OPTETRAK® HI-FLEX® Polyethylene Tibial Inserts (TKR)
- ARTHROFOCUS® Polyethylene Tibial Inserts (TKR)
- OPTETRAK® Custom Polyethylene Tibial Inserts (TKR)
- OPTETRAK® LOGIC® Polyethylene Tibial Inserts (TKR)
- OPTETRAK® RBK® Polyethylene Tibial Inserts (TKR)
- TRULIANT® Tibial Inserts (TKR)
- OPTETRAK® Logic RBK Tibial Components (TKR)
- Vantage® Fixed-Bearing Polyethylene Liner Component (TAR)
- Vantage® Mobile-Bearing Polyethylene Liner Component (TAR)
Hip Replacements (distributed in the U.S.):
- Acumatch GXL Acetabular Liners
- MCS GXL Acetabular Liners
- Novation GXL Acetabular Liners
- Exactech All Polyethylene Cemented Acetabular Cup
- Acumatch Conventional UHMWPE
- MCS Conventional UHMWPE
- MCS Conventional UHMWPE
Exactech Hip, Knee, and Ankle Replacement Injuries
Thousands of patients received Exactech hip, knee, and ankle implants over the past decade and have been or will be required to undergo revision surgery to replace failed components in connection with a series of device recalls in which the manufacturer admitted that the affected components were improperly packaged. The following are some examples of complications that may occur in patients with recalled Exactech implants:
- Implant loosening or fracture
- Pain and swelling
- Bone loss
- Dislocation of the replaced joint
- Clicking, grinding, or popping in the joint
- Instability of the replaced joint
- Inability to bear weight on the joint
- Increased risk of polyethylene wear
- Premature device failure
As a result of these painful and debilitating injuries, Exactech implant recipients have had to undergo revision surgeries long before the estimated life expectancy of their implants and at a much higher rate than should reasonably be expected for medical devices of this kind.
Link Between Exactech Implants and Complications
The problem with the recalled Exactech replacement systems is that the polyethylene components within the hip, knee, and ankle systems may prematurely degrade over time, causing inflammation that can lead to bone necrosis and osteolysis.
According to Exactech, most of the company’s knee and ankle implants manufactured since 2004 used polyethylene inserts that were packaged in “out-of-specification” (non-conforming) vacuum bags that exposed the inserts to oxygen prior to implantation. Exactech has warned that this increased oxygen exposure may cause the liners to degrade earlier than expected, potentially causing problems for implant recipients.
Exactech’s initial recall announcement acknowledges that polyethylene inserts used in the affected knee and ankle replacement systems were packaged in vacuum bags that were “oxygen resistant but [did] not contain a secondary barrier layer containing ethylene vinyl alcohol (EVOH) that further augments oxygen resistance.” Exactech warned that the defective packaging may have caused the inserts to become vulnerable to increased oxidation, which can lead to accelerated debris production and bone loss and cause the components to fracture, crack, or otherwise fail.
In an Urgent Medical Device Correction letter sent to Exactech knee and ankle surgeons, hospitals, and healthcare professionals in April 2022, the manufacturer stated that approximately 80% of the inserts manufactured since 2004 were packaged in these “non-conforming” vacuum bags. “The use of these non-conforming bags may enable increased oxygen diffusion to the UHMWPE (ultra-high molecular weight polyethylene) insert, resulting in increased oxidation of the material relative to inserts packaged with the specified additional oxygen barrier layer,” the letter reads. “Over time, oxidation can severely degrade the mechanical properties of conventional UHMWPE, which, in conjunction with other surgical factors, can lead to both accelerated wear debris production and bone loss, and/or component fatigue cracking/fracture, all leading to corrective revision surgery.”
After issuing the knee and ankle recall, Exactech identified similar problems with its hip replacement systems that use Connexion GXL hip implant liners or conventional (i.e. non-crosslinked) ultra-high molecular weight polyethylene (UHMWPE) acetabular liners that have been implanted since 2004. In light of these issues, the manufacturer has recalled these hip implant components and warned that hip replacement systems that use the recalled components may also be prone to premature wear and catastrophic failure.
Lawsuits Against Exactech for Implant Failure
October 2022 – Exactech product liability cases filed in federal courts across the country are consolidated into a multidistrict litigation (MDL) in New York.
December 2022 – An Exactech lawsuit filed in Tennesee and transferred to the MDL in New York alleges that a defective Truliant knee implant device degraded prematurely and caused plaintiff Billy Hursey to require revision surgery due to severe pain, swelling, and instability in the knee and leg.
March 2023 – A Maine woman alleges in an Exactech recall lawsuit that the knee replacement system she had implanted in both knees in 2012 was defective and caused her to suffer permanent and debilitating injuries. As stated in the claim, she required revision surgery in 2018, due to a number of complications associated with polyethylene wear, including pain, bone loss, and loosening of the implant.
April 2023 – A surge of new Exactech recall lawsuits brings the total number of pending cases in the federal Exactech MDL to nearly 300. Another 80 cases or more are pending in a state MDL in Florida.
Exactech Recalls and Warnings
June 2021 – Exactech recalls some GXL Connexion liners used in its Novation, Acumatch, and MCS hip replacement devices due to excessive and premature wear, but the root cause of the wear is unknown.
July 2021 – Exactech issues an urgent letter to healthcare providers worldwide, regarding the company’s Connexion GXL, moderately crosslinked polyethylene acetabular hip liners. The company warns that it has observed a “higher than expected number of cases in which the Connexion GXL liner exhibited early linear and volumetric wear with associated periacetabular and proximal femoral osteolysis [bone loss].”
July 2021 – The FDA classifies the GXL recall as a Class II recall.
August 2021 – The FDA announces a recall of a number of Exactech knee and ankle replacements made with polyethylene components and inserts due to concerns that unexpected exposure to oxygen may cause the devices to degrade.
October 2021 – The FDA classifies the Exactech knee and ankle recall as a Class II recall.
February 2022 – Exactech expands a voluntary recall of its Optetrak, Logic, and Truliant knee replacements and Vantage total ankle replacements packaged in defective bags regardless of the devices’ label or shelf life.
August 2022 – Exactech releases another urgent communication warning about similar problems with its Connexion GXL hip implant liners and conventional (i.e. non-crosslinked) ultra-high molecular weight polyethylene (UHMWPE) acetabular liners. The company indicates that the use of out-of-specification vacuum bags “may enable increased oxygen diffusion to the polyethylene insert resulting in increased oxidation of the material relative to inserts packaged with the specified additional oxygen barrier layer.”
September 2022 – The FDA classifies the recall of all hip devices with polyethylene components packaged in defective bags as a Class II recall.
March 2023 – A safety communication issued by the FDA reminds healthcare providers and the public that many of Exactech’s joint replacement devices manufactured between 2004 and August 2021 and recalled in 2021 and 2022 were packaged in defective packaging and could degrade early, leading to the need for revision surgery.
Exactech Joint Registry Data
Evidence of problems with Exactech joint devices implanted in Australia, New Zealand, and the United Kingdom suggests that the polyethylene inserts used in the recalled Exactech implants are failing at an alarming rate.
- The Australian Registry includes reports of 374 knee implant revision surgery procedures out of 3,684 Exactech Optetrak total knee replacements with a 14- to 20-year follow-up. Exactech indicates in an April 2022 letter that “Every Exactech Optetrak TKR [total knee replacement] polyethylene component combination demonstrated statistically significant increased revision rates compared to other TKR systems.”
- The UK Registry shows that the Exactech Optetrak knee replacement system using the cruciate retaining femoral component had “statistically significant” increased cumulative revision rates compared to all total knee replacements at years three, five, 10, 13, and 15.
- The New Zealand Registry includes reports of 63 knee implant revision surgery procedures out of 661 Optetrak knee replacements. According to Exactech, the revision rate for the Optetrak device was 1.015/100 component years, more than two times the revision rate for all other total knee replacements, which was 0.48/100 component years.
“Additionally, the reasons for revision potentially associated with polyethylene wear (e.g., loosening, lysis, pain) were increased three- to seven-fold in the most used Exactech Optetrak TKR combination (Optetrak-PS/Optetrak) which had a total of 263 TKR revision procedures among 2,410 primary TKRs when compared to other TKRs in the Australian Registry,” Exactech reports in the same April 2022 letter to Exactech knee and ankle surgeons, hospitals, and health care professionals. “The reasons for these increased revision diagnoses related to accelerated polyethylene wear may be related to the non-conforming packaging.”
Why We Think the Manufacturer Should be Held Liable
A growing number of product liability lawsuits filed in courts across the country seek to hold Exactech accountable for complications and injuries sustained by patients who received recalled Exactech hip, knee, and ankle implants. Each of these lawsuits involves similar allegations that the medical device maker:
- Manufactured defective hip, knee, and ankle implant components;
- Failed to properly package its polyethylene insert components;
- Knew or should have known that its polyethylene insert components were packaged in out-of-specification vacuum bags and were therefore susceptible to increased oxygen diffusion during shelf storage;
- Knew or should have known that the defect in the packaging posed a risk for component fatigue and damage after implantation;
- Allowed defective devices to be shipped and implanted by surgeons, despite evidence of poor clinical performance; and
- Failed to provide doctors and implant recipients with timely warnings about malfunctioning implants.
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What should you do? If you have suffered premature device failure, bone loss, or other complications leading to revision surgery allegedly due to a defective Exactech implant, you should contact a lawyer as soon as possible to discuss filing an Exactech lawsuit.
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Recalled Exactech hip, knee, and ankle implants are failing at an alarming rate. Financial compensation may be available to anyone who received an Exactech hip, knee, or ankle implant in the past ten years and experienced premature failure of the implant, resulting in the need for revision surgery. In some cases, the problems associated with the recalled Exactech hip, knee, and ankle replacements have caused so much pain, swelling, instability, lack of mobility, or decreased function in the joint, that the patient requires revision surgery to repair or replace the defective device. And not only can these revision surgeries be costly, they also pose their own risk of complications. Patients across the country who have suffered Injuries caused by defective inserts and liners in recalled Exactech hip, knee, or ankle implants may have grounds to pursue damages for their medical expenses, lost wages, loss of future income, and pain and suffering. Call our consumer advocates at Leading Justice today to see if you qualify to file an Exactech lawsuit.
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