BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITAN MODULAR SHOULDER - FRACTURE BODY

    MDR report key: 2230858 · Received August 26, 2011

    Report

    Report Number
    1651501-2011-00067
    Event Type
    Injury
    Date Received
    August 26, 2011
    Date of Event
    July 27, 2011
    Report Date
    August 26, 2011
    Manufacturer
    ASCENSION ORTHOPEDICS, INC.
    Product Code
    HSD
    PMA / PMN Number
    K100448
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN ASCENSION EMPLOYEE ATTEND THE REVISION SURGERY ON THE PT. BOTH THE TRUNNION OF THE HUMERAL BODY AND THE TITAN HUMERAL HEAD WERE VISUALLY INSPECTED. NOTHING WAS FOUND BETWEEN THE TWO DEVICES THAT WOULD IMPEDE THE ASSOCIATION OF THE TWO COMPONENTS. BOTH COMPONENTS WERE FOUND TO BE IN GOOD CONDITION. THE SURGEON REASSEMBLED THE PROSTHESIS IN-SITU. THE SURGEON THEN ATTEMPTED TO DISENGAGE THE TAPER BY PHYSICALLY PULLING ON THE HUMERAL HEAD. HE WAS UNABLE TO DISENGAGE THE COMPONENTS AND WAS SATISFIED THAT THE TAPER HAD LOCKED. THE CAUSE FOR THIS EVENT WAS NOT IDENTIFIED, BUT IT COULD BE SPECULATED TO BE RELATED TO SURGICAL TECHNIQUE.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM A SALES REP THAT A TITAN SHOULDER HEAD BECAME DISASSOCIATED FROM THE TITAN BODY AFTER SURGERY. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2011 WHERE THE TSS SHOULDER HEAD WAS RE-ATTACHED TO THE TSS BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TITAN MODULAR SHOULDER - FRACTURE BODY SHOULDER JOINT HUMERAL UNCEMENTED PROS. HSD ASCENSION ORTHOPEDICS, INC. BOD-0950-020-08STD 11-0199

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| R