(b)(4).Concomitant medical products: zimmer avenir stem remover, cat#01.06808.300, lot#16.344435.Zimmer avenir broach, cat#01.06620.004, lot#14.074465.Zimmer avenir neck provisional, cat#01.06520.000b, lot#14.085140.Biomet calcar planner, cat#110032334, lot#770330.Biomet calcar planner shaft, cat#110032332, lot#711160.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
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Reported event was confirmed by visual inspection of returned product.Visual inspection identified wear and tear on the taper consistent with use over a potential field age of approximately 2 years 9 months.Dimensional analysis confirmed that the product identifiers were conforming to print specifications where measured.No other issues were identified.Review of the device history records and receiving inspection reports identified no deviations or anomalies during manufacturing related to the reported event.A supplier dhr was not requested as there was wear and tear all over the device and on the taper's surface that was consistent with use over a potential field age of approximately 2 years 9 months.Additionally, the inner diameter and depth of the taper were measured and were found to be conforming to print specifications.A definitive root cause cannot 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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