(b)(4).Date of event, unknown date, 2013.Concomitant medical products: unknown coonrad/morrey ulnar.Reported event was confirmed through receipt of doctor's office notes.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Doctor's office notes from (b)(6) 2013 state, (b)(6) female presents with complaint of pain in her left arm.During the first quarter of year 2013 the patient experienced a gastric bleed requiring a large amount of blood transfusions and icu hospitalization for a time period of one month.During this time the patient was apparently moved; lifted and transferred utilizing her left arm.When the patient regained consciousness she was experiencing extreme pain and notable deformity of her left arm.When patient stabilized, displaced fracture of distal humerus, implant failure was identified.Patient has remained immobilized with a removable long-arm splint; however, healing of the wound has delayed with patient still recovering from abdominal surgery.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.Report was initially submitted incorrectly under report number 0001825034-2017-06938.
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