The contribution of the devices to the experience reported could not be determined as the devices were not returned for evaluation.Additionally, the device specific information was not provided, precluding a review of the device history record.Engineering evaluation noted that the revision reported was likely the result of excessive overall posterior tibil slope of the tibial insert (as defined by the posterior slope of the proximal tibial cut and the built-in slope of the insert), which allowed for excessive posterior contact between the femoral component and the tibial insert mainly on the medial aspect leading to catastrophic wear of the uhmwpe tibial insert.
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