BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITAN MODULAR TOTAL SHOULDER SYSTEM - HEAD

    MDR report key: 2050816 · Received April 1, 2011

    Report

    Report Number
    1651501-2011-00017
    Event Type
    Injury
    Date Received
    April 1, 2011
    Date of Event
    March 2, 2011
    Report Date
    April 1, 2011
    Manufacturer
    ASCENSION ORTHOPEDICS, INC.
    Product Code
    KWS
    PMA / PMN Number
    K100448
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE IMPLANT BODY WAS RETURNED AND STILL UNDER EVAL. THE INVESTIGATION DID REVEAL THAT THE SURGEON HAD PLACED A BIG STITCH THROUGH THE CAPSULE AND THROUGH THE STEM TO GET SOME STABILITY AS THERE WAS NOT MUCH TO HOLD THE PROSTHESIS IN THE JOINT FROM THE GUN SHOT WOUND. IT IS BELIEVED AT THIS TIME THE SUTURE MAY HAVE SLID UP UNDER THE HEAD AND PULLED IT OFF THE HUMERAL BODY TAPER. WHEN THE ANALYSIS IS COMPLETED, A SUPPLEMENT REPORT WILL BE FILED.

    Description of Event or Problem · 1

    A PT UNDERWENT SURGERY ON (B)(6) 2011, TO REPAIR THE LEFT SHOULDER OF A PT AFTER THE PT SUFFERED A GUN SHOT WOUND TO THE AREA. AN ASCENSION TITAN SHOULDER SYSTEM WAS PLACED IN THE PT. ON (B)(6) 2011, THE SURGEON REPORTED THAT THE HUMERAL IMPLANT HEAD DISASSOCIATED FROM THE HUMERAL IMPLANT BODY. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2011 TO CORRECT THE DISASSOCIATION BY REPLACING THE BODY IMPLANT WITH A NEW IMPLANT AND USING THE SAME ORIGINAL HUMERAL IMPLANT HEAD AND IMPLANT STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TITAN MODULAR TOTAL SHOULDER SYSTEM - HEAD SHOULDER JOINT METAL/POLYMER CEMENTED KWS ASCENSION ORTHOPEDICS, INC. MHH-0920-010-4015E 10-2085

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization| R