COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. INITIAL REPORTER IS ATTORNEY. (B)(4). WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
D
Patient 1
IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A REVISION OF RIGHT RADIAL HEAD REPLACEMENT DUE TO LOOSENING OF RADIAL STEM. ON AN UNKNOWN DATE, A PATIENT SUSTAINED A FALL ON HIS OUTSTRETCHED RIGHT UPPER EXTREMITY WHILE PAINTING FROM A LADDER AND PRESENTED WITH A SEVERE INJURY TO THE RIGHT UPPER EXTREMITY AS NOTED. GIVEN THE NATURE OF THE INJURY, HE WAS SEEN URGENTLY IN THE EMERGENCY ROOM AND URGENT SURGERY WAS DONE FOR BEST FUNCTIONAL OUTCOME. PREOPERATIVELY, PATIENT HAD SOME NUMBNESS IN THE ULNAR NERVE DISTRIBUTION, WHICH WAS LIKELY TRACTION TYPE INJURY SECONDARY TO TRAUMA. ON (B)(6) 2015, THE PATIENT UNDERWENT A RIGHT ELBOW RADIAL HEAD REPLACEMENT, CORONOID/LCL REPAIR, ORIF OF RADIAL STYLOID FRACTURE, CRPP OF SMALL FINGER/RINGER P1 BASE FRACTURE, PINNING OF MULTIPLE CARPAL BONES/FOURTH TO FIFTH CMC. OVER THE COURSE OF FOUR YEARS, THE PATIENT HAS BEEN DOING WELL WITH OCCASIONAL ELBOW PAIN WITH ACTIVITY, BUT WITH IMPROVEMENTS IN PAIN WHILE GOING WELL WITH OCCASIONAL THERAPY. ON (B)(6) 2019, THE PATIENT VISITED THE CLINIC FOR RIGHT ELBOW PAIN. RIGHT ELBOW CT DONE ON (B)(6). ON (B)(6) 2019, THE PATIENT HAD A FOLLOW-UP CHECK-UP AND REPORTS PAIN RADIATING FROM ELBOW TO THE DORSAL FOREARM. HE REPORTS PAIN ESPECIALLY WITH HEAVY ACTIVITY BUT DENIES PAIN AT REST. THIS REPORT IS FOR ONE (1) 26MM COCR RADIAL HEAD STANDARD HEIGHT/13.5MM-STERILE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).