This is report 2 of 3 for (b)(4).It was reported by j&j employee that under synthes complaint (b)(4) usage of mitek devices (gii® quickanchor® plus, single pack) was identified.Event description: "it was reported that the patient was revised due to metalosis.Ultamet metal liner/head.The hip joint was black and green with metal debris.Additional information event in the der reported osteolysis.Product issues was suspected and contributed to the event.Doi: unknown: dor: (b)(6), 2021: left hip.".
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This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by depuy mitek or its employees that the report constitutes an admission that the device, depuy mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).The lot number was unknown.D4, g1, h4: the lot number was unknown; therefore, the expiration date, manufacturing site name and device manufacture date were unknown.E3: reporter is a j&j employee.Investigation summary: the complaint device is not being returned, therefore unavailable for a physical evaluation.Since the complaint device was not returned, we cannot determine a root cause for the reported failure.If additional information or the device is received in the future, we will reopen the complaint and perform the investigation as appropriate.Given that an invalid lot number was provided, a manufacturing record evaluation (mre) review cannot be performed.If a valid lot number becomes available, the mre review will be performed.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.
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