BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TSS PRESS FIT STEM SZ. 14

    MDR report key: 9341012 · Received November 19, 2019

    Report

    Report Number
    1651501-2019-00044
    Event Type
    Injury
    Date Received
    November 19, 2019
    Date of Event
    October 17, 2019
    Report Date
    October 24, 2019
    Manufacturer
    ASCENSION ORTHOPEDICS
    Product Code
    KWS
    PMA / PMN Number
    K142413
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION, THEREFORE THE FAILURE MODE CANNOT BE CONFIRMED. DHR REVIEW SHOW THAT NO NONCONFORMANCES WERE GENERATED FOR THESE LOTS. THE COMPLAINT REPORTED CANNOT BE CONFIRMED. WITH THE INFORMATION PROVIDED, THE ROOT CAUSE IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2019, DURING A TOTAL SHOULDER ARTHROPLASTY REVISION SURGERY DUE TO DISLOCATION, THE STEM ( ID STEM-0920-025-14) SUBSIDED AND THE DOCTOR NEEDED TO GO UP A STEM SIZE AS WELL AS BODY AND LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1134602 TSS PRESS FIT STEM SZ. 14 TITAN TOTAL SHOULDER KWS ASCENSION ORTHOPEDICS 183854

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR BODY-BBS-0960-21STD LOT # 192488G| LINER-LNR-0960-06S LOT# 191190G