(b)(4).Reported event was confirmed with x-rays received.There is eccentric position of the prosthetic femoral head within the acetabular cup reflecting liner wear.There is periprosthetic lucency along the proximal femur and acetabulum that contains osseous trabeculae and is more consistent with osteopenia in part due to stress shielding than osteolysis.Device history record review was unable to be performed as the part and lot number of the device involved in the event is unknown.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-05609, 0001825034-2019-05785.
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