Complaint handling # (b)(4).Concomitant medical products: medical product: unknown tibial component, catalog #: unknown, lot #: unknown, medical product: unknown femoral component, catalog #: unknown, lot #: unknown.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00006, 3002806535-2020- 00005.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Product not returned.
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(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g4, h1, h6, h10.D11: medical product: unk oxford tibial component, catalog #: unknown, lot #: unknown.Medical product: unk oxford femoral component, catalog #: unknown, lot #: unknown.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00006-1, 3002806535-2020-00005-1.Biomet uk ltd have attempted to contact the sales representative, however, we have not been able to retrieve any further information relevant to this complaint.The product has not been returned to biomet uk ltd for evaluation, therefore, a thorough investigation has not been possible.In addition, we have not been provided with x-rays or any supporting documentation which could provide additional information.The item number and lot number identification necessary to review manufacturing history and the complaint history was not provided.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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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