The associated r3 3 hole acetabular shell, r3 0 deg xlpe acetabular liner and oxinium femoral head were not returned for evaluation.A clinical evaluation noted that no relevant supporting clinical information will be provided.Therefore based on insufficient information, no further clinical assessment can be performed at this time.Our investigation including a review of the manufacturing records for the shell and the liner did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the shell revealed no prior complaints for the listed failure mode with the same batch number.Without the return of the actual product involved, our investigation of this report is inconclusive.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.
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