Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/10/2021 |
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 a left side ef bottom tasp broke during a surgery while trialing a persona knee.The surgery was not affected and all pieces were recovered.
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Manufacturer Narrative
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(b)(4).Performed a visual inspection of the returned item found it to exhibit signs of repeated use and has fractured on the medial side of the post feature all pieces were returned reference attached photographs.Supplier dhr review found that the product was conforming to all specifications and no process deviations.Medical records were not provided.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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Event Description
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No further event information available at the time of this report.
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Search Alerts/Recalls
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