It was reported that ten years and six most post partial knee arthroplasty, the patient had to undergo a revision due to pain.During the procedure, it was noted that there was some wear to the bearing.Due diligence is in progress for this complaint; to date no additional information has been received.
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(b)(4).D10 - associated medical devices: oxf anat brg rt sm size 3 pma; item# 159568; lot# 2682445 oxf uni tib tray sz b rm pma; item# 154721; lot# unknown.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2024-00110 3002806535-2024-00111.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.
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(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: a1, a2, a4, b4, b5, b7, d4, g3, g6, h2, h4, h11.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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