Model Number N/A |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Information (3190)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).510k a similar device is cleared under k013042.Concomitant medical products: cp562391 disc lt dstl hmrl bdy set 050970, unknown discovery ulna, unknown articulation kit.The complaint is under investigation.Once the investigation is completed a follow up report will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 01387.
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Event Description
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It was reported that the patient underwent a total humeral/distal humeral replacement.Subsequently, the patient is being considered for a revision due to disassociation of the linkage between the distal humeral and total humeral components.No additional information is available at this time.
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Manufacturer Narrative
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The complaint cannot be confirmed as no medical records or x-rays were provided.Review of the device history records identified no deviations or anomalies.Root cause could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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No additional information is available to report at this time.
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Search Alerts/Recalls
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