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Model Number N/A |
Device Problem
Material Erosion (1214)
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Patient Problems
Local Reaction (2035); Metal Related Pathology (4530)
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Event Date 01/18/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical devices: catalog#: us157852 m2a-magnum pf cup 52odx46id lot#: 632810; catalog#: 11-103205 taperloc por lat fmrl 11x142 lot#: 502860; catalog#: 139256 m2a-magnum 42-50 tpr insrt std lot#: 468080.The device will not be returned for analysis, due to location of device is unknown; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-02055, 0001825034-2021-02060, 0001825034-2021-02062.
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Event Description
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It was reported that the patient underwent a revision procedure approximately 13 years and 4 months post implantation due to metal-on-metal ion disease.During the revision black synovial fluid was found.The stem, taper, cup and head were replaced without complications.Attempts have been made and additional information on the reported event is unavailable at this time.
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Event Description
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No further event information available at the time of this report.
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Manufacturer Narrative
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The event was confirmed with medical records provided: a review of the available records identified findings of the reported issues ebl 200 c, black synovial tissue fluid, which was sent for gram-stain, cell count, tb fungus, aerobic anaerobic culture sensitivity, and crystals.An aggressive synovectomy was performed due to lymphocytic disease.A review of the primary op records indicated no complications during the procedure.Device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to 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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Search Alerts/Recalls
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