This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified the porous coating is visually conforming and the stem is visually conforming to the print.Dimensional analysis of the product determined that the product, where measured, was conforming to print specifications.The device history records for part # 113610, lot #713330 were reviewed for deviations and/or anomalies with the following related anomalies/deviations identified: f13 width being oversized on all 11 pieces.All parts were reworked.All pieces were measured and found to be in specification after the rework; therefore it is not expected that the manufacturing process contributed to the reported issue.A definitive root cause cannot be determined.A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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