BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TORNIER HRS PTC DISTAL STEM DIA 11

    MDR report key: 18383177 · Received December 22, 2023

    Report

    Report Number
    0001649390-2023-00368
    Event Type
    Injury
    Date Received
    December 22, 2023
    Date of Event
    October 29, 2021
    Report Date
    December 22, 2023
    Manufacturer
    TORNIER INC
    Product Code
    KWS
    UDI-DI
    00846832093021
    PMA / PMN Number
    K181420
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL DEVICE USED UNKNOWN PROXIMAL BODY ARS655101 0MM SCREW DWF520 TORNIER FLEX SHOULDER SYS REV TRAY 0TH 3.5MM OFFSET DWF361C TORNIER FLEX SHOULDER SYS REV INSERT 36MM 6TH C 7.5DG DWJ401TORNIER PERFORM REVERSED STAND ARD BASEPLATE 25MM UNKNOWN GLENOID ¿ PERFORM REVERSED GLENOID, (6.5MM SCREW) DWJ012 TORNIER PERFORM REVERSED STANDARD GLENOSPHERE DIA 36MM BASED ON THE AVAILABLE INFORMATION THE DEVICE REMAINS IMPLANTED 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 ON A SUPPLEMENTAL REPORT. H3 OTHER TEXT : DEVICE REMAINS IMPLANTED IN PATIENT

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD PAIN ALONG THE ANTERIOR BASE OF THE INCISION. PATIENT WAS GIVEN AN INJECTION - 1ML KENALOG, 2ML LIDOCAINE, 7ML ROPIVACAINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2153624 TORNIER HRS PTC DISTAL STEM DIA 11 PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS TORNIER INC UNKNOWN 00846832093021

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Other ARS655101 TORNIER HRS SCREW| DWF361C TORNIER FLEX INSERT| DWF520 TORNIER FLEX TRAY| DWJ12 TORNIER GLENOSPHERE| DWJ401 TORNIER PERFORM BASEPLATE| UNKNOWN GLENOID 6.5 MM SCREW| UNKNOWN PROXIMAL BODY 0MM SCREW