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.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: ¿procedures: [left] arthrotomy elbow joint with total synovectomy and revision tea, ulnar and humeral components.Performed concurrently with open left carpal tunnel release¿, ¿she had a worn [left] elbow arthroplasty with the bushings that had failed, developed elbow pain and her carpal tunnel syndrome was symptomatic enough such that she wished the release.¿ the reported event is confirmed as medical records were provided.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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