(b)(4).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 3500a will be submitted.Concomitant medical products: m2a-magnum pf cup 52odx46id cat#us157852 lot#285770, taperloc por fmrl 11x142 cat#103205 lot#528650, m2a-magnum 42-50mm tpr insrt-3 cat#139254 lot#267160.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 04793, 0001825034 - 2019 - 04794, 0001825034 - 2019 - 04795.
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This follow-up report is being submitted to relay additional information.Reported event was confirmed with medical records provided.Review of revision operative notes state the patient was revised due to pain, elevated ion levels and altr.Radiographs indicate lucency around the acetabular shell and around the calcar.Difficulty removing the taper from the trunnion.Carbide bur was used to release it.Minor damage to the trunnion.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.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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