Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Ambulation Difficulties (2544)
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Event Type
Injury
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Event Description
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It was reported that the patient underwent a left knee arthroplasty.Subsequently, approximately fourteen years post-op, the patient started having some pain and difficulty walking.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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(b)(4).Concomitant medical products: unknown oxford femoral component item# unknown; lot# unknown.Unknown oxford tibial component item# unknown; lot# unknown.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 3500a will be submitted.If multiple reports submitted for the event, use following statement: multiple mdr reports were filed for this event, please see associated reports: 3002806535-2022-00262, 3002806535-2022-00264.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h1, h2, h6, h10.A manufacturing history review or a review of recalls could not be performed as the item and lot number have not been provided.The root cause of the reported event can not be determined with the information provided.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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