(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-03168, 0001822565-2023-03170, 0001822565-2023-03171.D10: unknown liner, unknown head, unknown stem.G2: australia.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
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(b)(4).This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The complaint is unable to be confirmed as no product information, event details or medical records were provided.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.A definitive root cause is unable to be established.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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