Catalog Number 159568 |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problems
Pain (1994); Joint Dislocation (2374)
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Event Date 10/09/2023 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
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Event Description
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It was reported that the patient underwent revision surgery due to dislocation.Due diligence is in progress for this complaint; to date no additional information or product has been received.
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Event Description
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It was reported that the patient underwent revision surgery due to dislocation of the bearing and pain.
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Manufacturer Narrative
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(b)(4).D10.Item#:unknown ;lot#: unknown ;item name: unknown femoral component ; item#:unknown ;lot#: unknown ;item name: unknown tibial component; this follow-up report is being submitted to relay additional information.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified that the spherical surface has some wear, dents and marks but is otherwise in good condition.A review of the device manufacturing records confirmed no abnormalities or deviations.Devices are used for treatment.Medical records were provided and reviewed by a health care professional.The review identified initial right partial knee replacement was performed, and subsequently the patient was revised two years and four months later due to anterior dislocation of the poly.During the revision components were found to have clean surfaces without defect, the poly was revised without complications.With the available information, a definitive root cause could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report 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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