Exactech Knee Replacement Recall Claims
The product liability lawyers at Jinks, Crow, and Dickson are investigating cases for injuries sustained by our clients from the recent Exactech knee replacement recall. The basis of the recall is a defect in the packaging which exposes the ultra-high molecular weight polyethylene (UHMWPE) liner to increased oxygen resulting in premature degradation of the polyethylene liner. The recall affects implants manufactured from 2004 through the recall.
In 2021, Exactech began a Class II Recall of certain total knee components for early wear due to the premature degradation of the polyethylene component, resulting in injuries to patients. This recall has been expanded to include all Exactech OPTETRAK®, OPTETRAK Logic®, or TRULIANT® knee replacements.
The Food and Drug Administration defines a Class II recall as a situation in which use or exposure to a product may cause medically reversible health complications.
Initially released in 2004, several hundred thousand of these devices have been implanted worldwide. In April 2022, Exactech admitted in a letter to surgeons that approximately 80% of their inserts manufactured since 2004 were packaged out-of-specification which caused increased oxygen diffusion to the UHMWPE (ultra-high molecular weight polyethylene) insert, resulting in increased oxidation which can severely degrade the properties of the polyethylene insert and can lead to both accelerated wear debris production and bone loss, component fatigue and cracking. This degradation can require corrective revision surgery.
Data from the Australian registry has shown that of the total knee replacement systems (TKR) studied in a 14-20 year follow up, every Exactech Optetrak TKR polyethylene component combination demonstrated statistically significant increased revision rates compared to other TKR systems.
The resulting injuries from the recalled Exactech devices include, but are not limited to:
Osteolysis/Loosening requiring revision of the component (replacement surgery)
New or worsening pain and swelling
Inability to bear weight
New or worsening clicking or grinding of the implant.
Additional injuries may result from the revision surgery, including but not limited to:
Additional revision surgeries
Bone loss and pain