Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problems
Failure of Implant (1924); Foreign Body In Patient (2687)
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Event Date 07/27/2023 |
Event Type
Injury
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Event Description
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It was reported the patient underwent a total knee arthroplasty.Postoperatively, a metallic piece was discovered in the patient by x-ray observation.As a result, the patient was revised 2 days post implantation.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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(b)(4).G2: foreign - japan.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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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.Pictures provided were insufficient to complete a visual or dimensional evaluations.The device history record was unable to be performed as the lot number of the device involved in the event is unknown.A definitive root cause cannot 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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Search Alerts/Recalls
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