Exactech, one of the leading manufacturers of implants used in joint-replacement surgery, announced August 11 that it was recalling 40,000 hip implants due to oxygen exposure that can degrade the polyethylene liners in the implants. This is the same problem that led the company in 2021 to face a recall of some of its knee and ankle implants manufactured in and after 2004.
The hip implant recall applies to the following models:
- Acumatch GXL
- Acumatch Conventional UHMWPE
- Exactech All Polyethylene Cemented Cup
- MCS Conventional UHMWPE
- Novation GXL, MSC GXL
- Novation Conventional UHMWPE
Exactech wrote a letter to surgeons earlier this year that said extensive testing by the company revealed that 80% of the implants manufactured in 2004 or later were packaged in vacuum bags that failed to meet company specifications (“non-conforming”). These vacuum bags were oxygen-resistant but did not contain a secondary barrier layer containing ethylene vinyl alcohol (EVOH) that further augments oxygen resistance.
The letter explained that the use of these non-conforming bags may have enabled increased oxygen diffusion to the ultra-high molecular weight polyethylene (UHMWPE) insert. This may have resulted in increased oxidation of the material compared to inserts packaged with the additional oxygen barrier layer specified by company schematics.
“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,” the letter said.
This recall brings the total number of recalled Exactech implant devices to over 250,000. The company was hit with a whistleblower lawsuit by three former employees in 2020, alleging that Exactech knowingly provided faulty implants to Medicare, Medicaid, and Department of Veterans Affairs beneficiaries.
According to Miller & Zois, LLC, Exactech has agreed to participate in a multidistrict litigation (MDL) rather than face individual lawsuits in several jurisdictions. The Judicial Panel on Multidistrict Litigation (JPML) lists 36 Exactech implant lawsuits spread over 11 federal districts. If the JPML agrees to consolidate the cases, the MDL will be adjudicated in the Eastern District of New York.