The associated complaint devices were returned and evaluated.A clinical investigation concluded that this complaint reports a revision approximately sixteen days post implantation due to loosening.There are no supporting clinical documents available.However, it was reported that the patient had poor bone stock and the cup shifted.The patient impact beyond the revision surgery is unknown, as there is no report of the patient¿s current condition or how the procedure was tolerated.A lab analysis revealed scratches and damage on the returned oxinium femoral head and the returned r3 liner.A review of complaint history did not reveal additional complaints for the listed batches.A review of the manufacturing records did not reveal any material or manufacturing deviations that could have caused or contributed to the reported incident.Based on the lack of information, the exact root cause for the loosening cannot be determined.A thorough clinical assessment cannot be performed.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.
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