(b)(4).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.Concomitant medical products: unknown, unknown stem, unknown.Unknown, unknown head, unknown.Unknown, unknown liner, unknown.Unknown, unknown cup, unknown.Events occurred in (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2017-06689.
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(b)(4).The reported event could not be confirmed based on limited information received.No products were returned; therefore, the visual and dimensional inspections were not performed.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Review of the complaint history determined that no further action is required.It could not be confirmed if the devices were used in an approved and compatible combination.A definitive root cause cannot be determined with the information provided.No corrective actions, preventive actions, or field actions resulted after investigation of this 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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