BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFORM REV INSERT SZ 3/4 36MM DIA +6 10 DG RET VE

    MDR report key: 20913212 · Received December 12, 2024

    Report

    Report Number
    0001649390-2024-00704
    Event Type
    Injury
    Date Received
    December 12, 2024
    Date of Event
    September 13, 2024
    Report Date
    December 12, 2024
    Manufacturer
    TORNIER INC
    Product Code
    PAO
    UDI-DI
    00846832078615
    PMA / PMN Number
    K201315
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE AVAILABLE INFORMATION THE DEVICE WILL NOT BE RETURNED THEREFORE AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY IS NOT POSSIBLE BECAUSE THE LOT NUMBER WAS NOT COMMUNICATED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    AS REPORTED: "SUBJECT: (B)(6) PHS STUDY: SCAPULAR FRACTURE. PT WAS DOING PLATES AND STRENGTH TRAINING WITH SUDDEN ONSET OF SEVERE LEFT SHOULDER PAIN GOING FROM SORE TO UNABLE TO RAISE LEFT ARM. PATIENT WAS DIAGNOSED WITH AN ACROMIAL FRACTURE (B)(6) 2024 AND RETURNED TO CLINIC (B)(6) 2024 WITH SHOULDER RECOVERING. ACTIONS TAKEN: REHABILITATION (BONE STIMULATOR) & TREATMENT/MEDICATION (SLING AT ALL TIMES, 3-4 WEEKS, DICLOFENAC AND TYLENOL FOR MILD TO MODERATE PAIN). AE UPDATE 14 NOV 2024: DESCRIPTION OF UPDATE: PATIENT HAS RECOVERED WELL AND CLINIC TEAM HAS ADVISED SHE CONTINUES TO TRANSITION INTO ALL ACTIVITIES AS TOLERATED WHILE USING BONE STIMULATOR FOR ANOTHER 6 WEEKS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1959901 PERFORM REV INSERT SZ 3/4 36MM DIA +6 10 DG RET VE PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER + ADDITIVE, CEMENTED PAO TORNIER INC UNKNOWN 00846832078615

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female Required Intervention