(b)(4).Concomitant medical devices: oxf anat brg rt mdsize 3 pma; item# 159575; lot# 816870; oxf uni cmntls tib szd rm; item# (b)(4); lot# r3050482a.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2022-00290, 3002806535-2022-00291, 3002806535-2022-00292.The device history records for were reviewed for deviations and / or anomalies and no discrepancies related to the reported event were found.Review of x-ray images (6week post-op and 3 year post-op) show overall fit, alignment, and bone quality appear normal.There are no signs of loosening, wear, radiolucency, or other contributing factors.Soft tissues are normal, no hardware or bone fractures present.There are no other concerns noted that would lead to the patient's complaint of pain/catching sensation.The root cause of the event was unable to 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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