Model Number N/A |
Device Problem
Unintended Movement (3026)
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Patient Problem
Joint Dislocation (2374)
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Event Date 08/09/2022 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Report source- foreign: austria.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 had an initial right knee arthroplasty and approximately 1.5 years later a revision surgery was performed due to the luxation of the inlay.It was also reported that the surface of the explanted product was not as smooth as expected.Due diligence is in progress for this complaint; to date no additional information or product has been received.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.Device is used for treatment.Medical records were not provided.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a follow-up report will be filled accordingly.
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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.Visual examination of the returned product identified severe pitting/indentations on both articulating surfaces.With the information provided it cannot be determined what has caused this reported event.The bearing has been implanted for 1 year and 5 months.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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