Catalog Number 574202065 |
Device Problems
Positioning Failure (1158); Difficult to Insert (1316); Inadequacy of Device Shape and/or Size (1583)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/08/2024 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
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Event Description
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It was reported that during the procedure, the stem did not implant correctly after trialing.It was noted to have sank too easily into position and it was loose.Another stem was used to complete the procedure.Attempts have been made and no further information is available.
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Event Description
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No additional event information to report at this time.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.Proposed component code: mechanical (g04)- stem.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The complaint could not be confirmed.Dhr was reviewed and no discrepancies related to the reported event were found.A definitive 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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Search Alerts/Recalls
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