Model Number N/A |
Device Problem
Manufacturing, Packaging or Shipping Problem (2975)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/05/2023 |
Event Type
malfunction
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Event Description
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It was reported that during knee arthroplasty when the articular surface was removed from the sterile packaging, a hair was identified on the surface of the device.No adverse events were reported as a result of this malfunction.
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Manufacturer Narrative
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(b)(4).The complainant has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.H3 other text : investigation incomplete.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Visual evaluation of the picture provided identified hair-like debris on the implant.However, as the product was previously opened, the source of debris could not be confirmed.The device history records were reviewed and no discrepancies were identified.As the condition of the device was unknown when it left zimmer biomet, a definitive root cause could not be determined with the information 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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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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