Catalog Number 00771101220 |
Device Problems
Defective Component (2292); Component or Accessory Incompatibility (2897)
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Patient Problem
No Information (3190)
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Event Date 03/16/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Product has been received by zimmer biomet and 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 a knee arthroplasty the femoral stem was too small to be press in the femoral canal after the surgeon reamed with a broach corresponding to the size of the stem.The surgeon reamed to a larger size and the component fit without issue.No additional patient consequences were reported.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was not confirmed.A m/l taper stem was returned for evaluation.As returned, the stem is in excellent condition.The stem was inspected on comparator confirming size in the a/p and m/l view.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined, as the reported event could not be substantiated.A summary of the investigation has been sent to the complainant.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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It was reported that during a total hip arthroplasty the femoral stem was allegedly too small to be press-fit into the femoral canal after the surgeon reamed with a broach corresponding to the size of the stem.The surgeon reamed to a larger size and the component fit without issue.No additional patient consequences were reported.
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Search Alerts/Recalls
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