Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported that a tibial provisional was returned through the worn instrument program, fractured.Attempts have been made and no further information has been provided.
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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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Complaint sample was evaluated and the reported event was confirmed.Returned device exhibited signs of repeated use and is fractured on medical side of post.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Based on the state of device and the age of the device when returned it is considered that the wear is a result of the operational context.The root cause can be attributed to wear from use.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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