(b)(4).Concomitant medical products: unknown liner, pn unknown, ln unknown.Unknown cup, pn unknown, ln unknown.Unknown stem, pn unknown, ln unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-00993, 0001822565-2019-00995, customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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It was reported that patient is experiencing grinding noise, metal shards in blood and weak muscles causing the joint to slip approximately 9 years post-implantation.A revision procedure has been indicated; however, it has not been reported at this time.Attempts were made to obtain additional information; however, none was available.
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