Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problems
Erosion (1750); Pain (1994); Local Reaction (2035)
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Event Date 08/12/2015 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Customer has indicated that the product will not be returned due to product location unknown to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: part: 11-103208 name: taperloc por lat fmrl 15x150 lot: 801650.Part: 139266 name: m2a-magnum 52-60 mm tpr insrt-3 lot: 811200.Part: us157858 name: m2a-magnum pf cup 58odx52id lot: 203850.Multiple mdr reports were filed for this event, please see associated reports (reference 0001825034-2017-02350).
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Event Description
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It was reported that a patients right hip was revised approximately 5 years post implantation due to pain.The head and cup were removed.Signs of metallosis were found during the revision.Evidence of head erosion found as well as signs of adverse local tissue reactions around some of the sclerotic bone in the greater trochanter region.Stress shielding behind the cup was also found.
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Manufacturer Narrative
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Reported event was confirmed by review of op notes.Revision operative findings show surgeon noted the metal tinged fluid with reactive lymphocytes and the capsule was found to be consistent with an actue local tissue reaction secondary to the metallosis, sclerotic bone erosion, and stress shielding behind the cup.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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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