(b)(4).Concomitant medical products: 211254, compr srs 60mm dst hml bdy rt, 952960, 114817, disc ulna 3x115mm rt w/brng c, unknown, unknown, unknown discovery humeral condyle kit, unknown, 211270, compr srs large flange, 916200.Report source, foreign - the event occurred in the (b)(6).Reported event was unable to be confirmed due to limited information received from the customer.The product was not returned for the investigation, therefore a visual and dimensional evaluations could not be performed.X-rays were submitted to mmi for review.Overall fit and alignment of the implants is appropriate.There is likely osteopenia present.Radiolucency is noted along the ulnar component which is suggestive of loosening.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the report event was not reported.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.This report is being submitted late as it has been identified in remediation.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 04151, 0001825034 - 2018 - 04152, 0001825034 - 2018 - 04153, 0001825034 - 2018 - 04154.Product location unknown.
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It was reported that the patient underwent right shoulder arthroplasty.During a one and three year follow up appointment, the patient experienced moderate to severe pain, difficulty sleeping, moderate tingling, difficulty opening a jar, difficulty doing heavy chores, difficulty carrying a bag, difficulty cutting, washing back, limited in social activities, and limited/ unable to do daily and recreational activities.Attempts have been made and additional information on the reported event is unavailable.
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