Catalog Number 51-106110 |
Device Problems
Off-Label Use (1494); Device Contaminated During Manufacture or Shipping (2969); Packaging Problem (3007)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/03/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product remains implanted.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 was reported that during an initial hip procedure the surgeon noticed the packaging was recompressed with scratch marks on the packaging leading the surgeon to question sterility.The device was soaked in betadine before implantation.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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Reported event was unable to be confirmed.Device history record (dhr) was reviewed and no discrepancies were found.The condition of the device when it left zimmer biomet cannot be determined as product has not been returned, and photographs have not been provided.Previous investigations into the reported event identified that the reported event can be attributed to transit damage, however, the root cause cannot 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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Event Description
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No further event information available at the time of this report.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The root cause of the implant being soaked in betadine can be attributed to the surgeon not following instructions as listed in the instructions for use.A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device.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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