Description of Event or Problem · 0
ON (B)(6) 2024. THE PATIENT HAD A SHOULDER ARTHROSCOPY WITH A STRYKER INSPACE BALLOON IMPLANTED WITHOUT ANY VISIBLE COMPLICATIONS. THE PRODUCT REP AND SURGEON SAID IT WAS SUCCESSFUL. ON (B)(6) 2024, THE PATIENT FELL AND INJURED HIS SHOULDER WHILE TRYING TO CATCH HIMSELF DURING THE FALL. ON (B)(6) 2024, A SHOULDER X-RAY SHOWED A NEW TINY MAN-MADE DENSITY PROJECTING BETWEEN THE ACROMION AND THE HUMERAL HEAD MEASURING 4X1 MM. ON (B)(6), AN ULTRASOUND OF THE SHOULDER SHOWED "A SMALL AMOUNT OF FLUID IS IDENTIFIED IN BETWEEN THE ACROMION AND HEAD OF THE HUMERUS. MORE INFERIOR AND DEEPER, ALONG THE PROXIMAL/MEDIAL HUMERAL HEAD THERE IS A COLLECTION OF FLUID MEASURING 3.4 X 2.2 X 2.3 CM." SHOULDER X-RAY ON (B)(6) 2024 SHOWED "THERE IS A RELATIVELY SIMILAR APPEARANCE OF THE RIGHT SHOULDER. THERE IS A METALLIC CLIP IN THE SUBACROMIAL SPACE. THERE ARE SMALL SPURS AT THE LATERAL MARGIN OF THE ACROMION PROCESS. THE EXAMINATION IS OTHERWISE UNREMARKABLE WITHOUT EVIDENCE OF FRACTURE OR MALALIGNMENT." ON (B)(6) 2024, THE PATIENT HAD SURGERY TO REMOVE THE FAILED IMPLANT. FINDINGS WERE "REMOVAL STRYKER IN SPACE BALLOON REMOVED INTACT WITHOUT FLUID WITH METAL FRAGMENT INSIDE IT." PER THE SURGEON, THE TIP OF THE INFLATION CANNULA BROKE OFF IN THE NECK OF THE BALLOON. THE CANNULA CANNOT BE OBSERVED PRIOR TO SURGERY FOR A COMPARISON AFTER SURGERY. HAD THE PATIENT NOT FALLEN AND SOUGHT TREATMENT, THE BALLOON WOULD HAVE DISSOLVED AND THE FRAGMENT WOULD HAVE FALLEN INTO THE JOINT SPACE.