Model Number N/A |
Device Problem
Device Contaminated During Manufacture or Shipping (2969)
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Patient Problem
No Patient Involvement (2645)
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Event Date 07/11/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).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.Multiple mdr reports were filed for this event, please see all associated reports: 0001825034-2018-05895, 0001825034-2018-05897.
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Event Description
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It was reported that during incoming inspection of product, debris was found in the sterile package.No adverse events have been reported as a result of the malfunction.Attempts have been made and additional information on the reported event is unavailable at this time.
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Manufacturer Narrative
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(b)(4).Complaint sample was evaluated and the reported event was confirmed.Visual inspection of the box confirmed there was debris found within the sealed package.Mftir spectrum analysis for lot # 772930 revealed that the debris was made of ultra-high molecular weight polyethylene (uhmwpe).Device history record (dhr) was reviewed and no discrepancies were found.The likely condition of the product when it left zimmer biomet was non-conforming.The root cause of the reported event is the operator not following instructions during the manufacturing process.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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