BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TORNIER HRS ASSEMBLY SCREW 50MM

    MDR report key: 25113222 · Received May 7, 2026

    Report

    Report Number
    0001649390-2026-00407
    Event Type
    Injury
    Date Received
    May 7, 2026
    Date of Event
    April 7, 2026
    Report Date
    May 7, 2026
    Manufacturer
    TORNIER INC
    Product Code
    HSD
    UDI-DI
    00846832093298
    PMA / PMN Number
    K181420
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141774 TORNIER HRS ASSEMBLY SCREW 50MM PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED HSD TORNIER INC AZ4123363 00846832093298

    Patients

    Seq Age Sex Outcome Treatment
    1