(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2018-05980, 0001822565-2018-05981, 0001822565-2018-05983, 0001822565-2018-05985, 0001822565-2018-05986, 0001822565-2018-05988, 0001822565-2018-05989, 0001822565-2018-05990, 0001822565-2018-05992, 0001822565-2018-05995, 0001822565-2018-05996, 0001822565-2018-05998, 0001822565-2018-05999, 0001822565-2018-06001, 0001822565-2018-06002, 0001822565-2018-06003, 0001822565-2018-06004, 0001822565-2018-06006, 0001822565-2018-06008, 0001822565-2018-06010, 0001822565-2018-06011, 0001822565-2018-06012, 0001822565-2018-06014, 0001822565-2018-06015.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.Product not returned.
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Report source foreign ¿ (b)(6).Visual examination of the returned products identified that 13 pieces from lot # 64053676, 11 were found conforming and two pieces failed and 12 pieces from lot # 64021728 were found to be conforming.Device history record was reviewed and no discrepancies were found.There was no issue found with the product.The device evaluation found no malfunction and the event did not contribute to injury, therefore this would not be considered a reportable event.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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