BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFORM COCR HUMERAL HEAD 43X16

    MDR report key: 23642311 · Received November 25, 2025

    Report

    Report Number
    0001649390-2025-00849
    Event Type
    Injury
    Date Received
    November 25, 2025
    Date of Event
    June 6, 2025
    Report Date
    November 25, 2025
    Manufacturer
    TORNIER INC
    Product Code
    HSD
    UDI-DI
    00846832084173
    PMA / PMN Number
    K201315
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT COULD NOT BE CONFIRMED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCE WERE PROVIDED. A DEVICE INSPECTION WAS NOT POSSIBLE SINCE THE AFFECTED DEVICE WAS NOT RETURNED. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. A REVIEW OF THE DEVICE HISTORY WAS NOT POSSIBLE BECAUSE THE LOT NUMBER WAS NOT COMMUNICATED. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. INDICATIONS OF MATERIAL MANUFACTURING OR DESIGN RELATED PROBLEMS WERE UNABLE TO BE IDENTIFIED AS THE LOT NUMBER WAS NOT COMMUNICATED. IF THE DEVICE IS RETURNED OR IF ANY ADDITIONAL INFORMATION IS PROVIDED THE INVESTIGATION WILL BE REASSESSED.

    Description of Event or Problem · 0

    SUBJECT: (B)(6). PERFORM HUMERAL SYSTEM STUDY (PHS). UNEXPECTED PAIN NOT RELATED TO SURGICAL RECOVERY. SUBJECT CONTACTED SURGEON'S OFFICE WITH COMPLAINTS OF PAIN. SUBJECT COMPLETED A COURSE OF PHYSICAL THERAPY AND UNDERWENT AN ULTRASOUND WHICH SHOWED MILD BURSITIS. SUBJECT WAS STILL EXPERIENCING PAIN AT TWO-YEAR POST-OP VISIT AND RECEIVED A STEROID INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2851940 PERFORM COCR HUMERAL HEAD 43X16 PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED HSD TORNIER INC UNKNOWN 00846832084173

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Other