Model Number N/A |
Device Problem
Packaging Problem (3007)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/28/2022 |
Event Type
malfunction
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Event Description
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It was reported that during a knee procedure, the implant sterile packaging was damaged and it appeared the sterility had been compromised.The procedure was completed with a different implant.No adverse events have been reported as a result of the malfunction.
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Manufacturer Narrative
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(b)(4).Foreign source: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of photographs.Visual examination of the provided pictures found damage to the outer carton.Both of the inner and outer sterile blisters exhibit damage.Sterility has been breached.Device history record was reviewed and no discrepancies relevant to the reported event were found.The root cause of the reported event can be attributed to transit damage.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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