(b)(4).Medical product: catalog #: 00434904003, poly liner plus 3 mm offset 40 mm diameter, lot # 64531924; catalog #: 00434904003, poly liner plus 3 mm offset 40 mm diameter, lot # 64531924; catalog #: 00430902800, liner impactor 40 mm, lot # unknown.Report source- (b)(6).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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2021-01658, 0001822565-2021-01659.Returning.
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It was reported when we tried to impact the offset poly onto the stem, the surgeon couldn't make it fit, as there appeared to be a an issue with the poly fitting to the stem.The poly liner seemed to have an incorrect shape.We tried a subsequent poly which also failed with the same problem.In the end we used a 9mm spacer with a 0mm offset poly.Had to try a second poly, then use a spacer and new poly liner and use cerclage wires and because of the excessive impacting of a malshaped poly the humeral bone fractured.Delay of 20 minutes occured.They had to try a second poly, then use a spacer and new poly liner and use cerclage wires.Attempts have been made and there is no further information at this time.
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(b)(4) reported event was confirmed as visual examination of the returned products identified both liners exhibited damage/witness marks on the backside at the slot indicating they were not properly aligned during the attempts to install.Both slot widths were conforming to print specifications.Device history record was reviewed and no discrepancies relevant to the reported event were found.The root cause of the reported issue is attributed to use error, misalignment of poly liners to the humeral stem.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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