Catalog Number 00575201706 |
Device Problem
Tear, Rip or Hole in Device Packaging (2385)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/17/2016 |
Event Type
malfunction
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Manufacturer Narrative
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This report will be amended when our investigation is complete.
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Event Description
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It is reported that when the knee implant was opened, the plastic casings were cracked, compromising sterility and making the device unusable.
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Manufacturer Narrative
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Reported event was unable to be confirmed due to limited information received from the customer.No product was returned; from the evaluation of received photos, it was determined that the one cavity was cracked, it is unknown whether other cavity cracked or not and it is also unknown whether it's inner or outer.Device history record was reviewed and no discrepancies relevant to the reported event 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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