(b)(4).Concomitant medical products: 32673200501 ¿ xlpe liner ¿ unknown lot; 00902603300 ¿ cocr head ¿ unknown lot; unknown stem ¿ unknown part and lot.Reported event was confirmed by review of x-rays reviewed by a third party hcp noting left total hip arthroplasty with screw fixation of the acetabular cup.There is a superior dislocation of the femoral head from the cup with suggestion possible fracture of the liner.Vertical position of the cup likely predisposes the patient to dislocation.There is also noted osteopenia.Dhr was unable to be reviewed as the lot number of the device is unknown.The root cause is unable to be determined.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-01620, 0002648920-2020-00247.Device remains implanted.
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