Model Number N/A |
Device Problems
Fracture (1260); No Apparent Adverse Event (3189)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/03/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The 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 is reported that the impactor pad fractured upon impaction during right knee arthroplasty.No adverse events were reported as a result of this event.
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Manufacturer Narrative
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The complaint sample was evaluated and the reported event was confirmed through physical evaluation.The returned impactor pad showed signs of repeated use (nicked or gouged) and was confirmed to be fractured off from the center.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not 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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