BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI HUMERAL STEM PRESS-FIT SIZE 6/115MM-STERILE

    MDR report key: 2998138 · Received March 11, 2013

    Report

    Report Number
    1719045-2013-00499
    Event Type
    Injury
    Date Received
    March 11, 2013
    Report Date
    February 12, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    KWT
    PMA / PMN Number
    K072578
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. ADDITIONAL PRODUCT CODES - MBF, HSD.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH EPOCA SHOULDER ARTHROPLASTY SYSTEM FOR A FRACTURE ON (B)(6) 2011. AT THIS TIME, SURGEON REPAIRED PATIENTS TRAUMA STEM AND ROTATOR CUFF. POST-OPERATIVELY, ON AN UNKNOWN DATE, PATIENT PRESENTED AN ERODED SOFT TISSUE ELEMENT OF THE SHOULDER REGION. PATIENT RETURNED TO THE O.R. ON (B)(6) 2013 FOR HARDWARE REMOVAL. PATIENT WAS REVISED WITH COMPETITORS HARDWARE. REVISION WAS COMPLETED SUCCESSFULLY. THIS IS 2 OF 5 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101865 TI HUMERAL STEM PRESS-FIT SIZE 6/115MM-STERILE KWT SYNTHES MONUMENT C000028

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention