TORNIER HRS ASSEMBLY SCREW 50MM

Description of Event or Problem

IT WAS REPORTED THAT, THE INDICATION FOR WHICH THE IMPLANT WAS INITIALLY USED WAS PERI-IMPLANT INFECTION AFTER PROXIMAL HUMERAL PLATING FOR POSTERIOR FRACTURE DISLOCATION. IMPLANT REMOVAL. AFTER CALMING OF THE INFECTION IMPLANTATION OF REVIVE-STEMP WITH PYC. THIS PRIMARY SURGERY OCCURRED, IN (B)(6) 2025, USING THE TORNIER HRS SYSTEM. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2026, THE PATIENT CAME IN FOR A FOLLOW-UP VISIT. AT THE END OF THE EXAMINATION, HE COMPLAINED OF A CLICKING SOUND. AN X-RAY EXAMINATION REVEALED THAT THE PROSTHESIS HAD BECOME DISCONNECTED. THE LOOKING CAP AND THE ASSEMBLY SCREW HAD COME LOOSE. HOWEVER, THE PATIENT HAS NO COMPLAINTS AND IS COMPLETELY PAIN-FREE. MOBILITY IS UNRESTRICTED. THE SURGERY WAS REPORTEDLY PERFORMED PROPERLY, AND A MATERIAL DEFECT IS SUSPECTED BY THE CUSTOMER. ADDITIONAL INFORMATION WAS RECEIVED THAT, FOLLOWING THE INITIATION OF STRUCTURED LOAD- BEARING (EQUIPMENT TRAINING) AFTER THE IMPLANTATION IN (B)(6) 2025 OF A MODULAR RIGHT SHOULDER HEMI-PROSTHESIS, THE PATIENT SUBSEQUENTLY NOTICED CRACKING AND GRINDING NOISES. THE PATIENT WAS HIGHLY ACTIVE BEFORE SHOULDER REPLACEMENT. STRICTLY FOLLOWED ALL INSTRUCTIONS AND VERY COMPLIANT. MOBILIZATION INSTRUCTIONS FROM THE SURGEON INCLUDED NORMAL POSTOPERATIVE PROTOCOL AFTER SHOULDER REPLACEMENT. 4-6 WEEKS BRACE IN NEUTRAL ROTATION. ACTIVE EXERCISES STARTING FROM WEEK 6. FULL WEIGHT AFTER 3 MONTHS. UPON EXPLICIT ENQUIRY, THE PATIENT DENIED ANY ACCIDENT OR MINOR TRAUMA. RADIOLOGICALLY, DURING THE PLANNED POST-OPERATIVE FOLLOW-UP IN (B)(6) 2026, DISCONNECTION OF THE MODULAR STEM COMPONENTS WAS CONFIRMED. SURGICAL REVISION WITH REPLACEMENT OF THE IMPLANT COMPONENTS WAS INDICATED.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.