(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation product location is unknown.Concomitant medical products: part # 00771101010/ femoral stem / lot #62645290, part # 00875705201/ shell / lot #62674908, part #00625006525/ bone screw / lot #62698746, part #00625006525/bone screw/ lot #62690221, part # 00877503201/biolox head/ lot # 2720466.Reported event was able to be confirmed by medical records review.The review confirmed instability, limb length discrepancy of more than 2cm, significant rheumatoid reactive tissues requiring extensive synovectomy, and previous dislocations resulting in a large tissue defect.Implants and tissue were sent to pathology however there no report is attached to review.From the revision surgery, final components were placed and limb lengths were equalized; there is good range of motion with no impingement and the wound was irrigated and closed in layers.Dhr was reviewed and no discrepancies relevant to the reported event were found.Review of complaint history found no additional related issues for this item and the reported part and lot combination.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.
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