TORNIER SIMPLICITI HUM HEADSIZE 5 0X16

Additional Manufacturer Narrative

THE REPORTED EVENT COULD NOT BE CONFIRMED SINCE NO OTHER EVIDENCE WAS PROVIDED. THE RETURNED DEVICE INSPECTION REVEALED THE FOLLOWING THE IDENTIFICATION OF THE DEVICE IS CONFIRMED. BONE AND SOFT TISSUE RESIDUES ARE OBSERVED ON THE DEVICE. SURFACES OF THE DEVICE ARE DEGRADED SCRATCHES, PITTING MARKS, DEFORMED MATERIAL AND EDGES. SINCE IMAGES AND INFORMATION WERE PROVIDED, THE OPINION OF A MEDICAL EXPERT WAS SOUGHT AND STATED AS FOLLOWS: BOTH THE HUMERAL AND GLENOID COMPONENTS ARE WELL-POSITIONED. THIS WAS ALSO MENTIONED IN THE NOTES OF THE COMPLAINT THAT HUMERAL IMPLANTS WERE WELL FIXED. NO SPECIFIC FACTORS, ESPECIALLY NO DECENTERING OF THE HUMERAL COMPONENT RELATIVE TO THE GLENOID. CONSEQUENTLY, NO CLEAR RADIOLOGICAL SIGNS OF ROTATOR CUFF DYSFUNCTION. THERE IS A RADIOLUCENT LINE AROUND AT THE GLENOID COMPONENT-BONE INTERFACE. RADIOLOGICALLY NO ABSOLUTE SIGNS OF LOOSENING NO MIGRATION, INTRAOPERATIVELY IT WAS MENTIONED, HOWEVER. NO UNINTENDED HUMERAL HEAD-GLENOID MISMATCH ON THE X-RAY. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED.

Description of Event or Problem

IT WAS REPORTED THAT, THE PATIENT UNDERWENT A RIGHT PRIMARY ANATOMIC SHOULDER REPLACEMENT ON (B)(6) 2024. ADVISED BY SURGEON YESTERDAY THAT THE PATIENT NOW REQUIRES A REVISION (REMOVAL OF ALL IMPLANTS), AND CONVERSION TO A REVERSE SHOULDER REPLACEMENT, AS THE PATIENT'S ROTATOR CUFF HAS FAILED. THE SURGERY WAS SCHEDULED FOR (B)(6) 2026. RIGHT PRIMARY SHOULDER ARTHROPLASTY ON 6.8.24. PATIENT HAD BEEN COMPLAINING OF DISCOMFORT IN PROSTHETIC RIGHT SHOULDER JOINT APPROX 6 MONTHS POST-OP. X-RAY AT THIS TIME SHOWED SOME EVIDENCE OF LUCENCY AROUND GLENOID COMPONENT. CT SCAN AT 12 MONTHS POST-OP SHOWED INCREASING LUCENCY, HE COMPLAINED OF MORE DISCOMFORT. CT SCAN LATE 2025 SHOWED LOOSE GLENOID COMPONENT, REVISION SURGERY BOOKED. SIMPLICITI HEAD REMOVED, SIMPLICITI NUCLEUS WAS SOLID, BUT THE REVISION TOOLS GOT IT OUT QUITE CLEAN. MINIMAL BONE LOSS. GLENOID PERFORM PLUS POLY WAS VERY LOOSE, CAVITY BEHIND IT. COMPONENT HAD MINIMAL CEMENT STILL ADHERED TO IT. MULTIPLE TISSUE SAMPLES TAKEN, THOUGH SURGEON STATED THAT THERE WERE NO CLINICAL SIGNS OF INFECTION. COPIOUS LAVAGE. SHOULDER JOINT REDUCED, STABLE THROUGH FULL RANGE OF MOTION. EXPLANTED PROSTHESIS BEING RETURNED (IN A STERI-PEEL PKT) WITH LOAN INSTRUMENTS.