BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOST OPTIONS NON-POROUS TIBIAL ADAPTER

    MDR report key: 1203170 · Received October 9, 2008

    Report

    Report Number
    1822565-2008-00691
    Event Type
    Malfunction
    Date Received
    October 9, 2008
    Date of Event
    September 9, 2008
    Report Date
    September 9, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE SURGEON HAD ASSEMBLED A STEM (TYPE NOT SPECIFIED) AND A MOST OPTIONS TIBIAL NON-POROUS ADAPTER. THE SALES REP DESCRIBED USING A SCREW WITH THE INTENT OF LOCKING THE TAPERS OF THESE TWO COMPONENTS TOGETHER. IT WAS NOT SPECIFIED IF A SCREW FROM THE STEM PACKAGE OR A SCREW FROM THE TIBIAL ADAPTER WAS USED. THE ASSEMBLY WAS THEN IMPACTED INTO A MOST OPTIONS PROXIMAL FEMUR. AFTER IMPACTION OF THE TIBIAL ADAPTER TO THE PROXIMAL FEMUR, THE SURGEON OBSERVED THAT THE STEM WAS LOOSE IN THE TIBIAL ADAPTER. THE SURGEON ATTEMPTED TO SEPARATE THE TIBIAL ADAPTER AND THE PROXIMAL FEMUR WITH A MOST OPTIONS TAPER SEPARATOR. IT WAS REPORTED THAT THE TAPER SEPARATOR FRACTURED BEFORE THE TAPERS COULD BE DISASSOCIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOST OPTIONS NON-POROUS TIBIAL ADAPTER KNEE PROSTHESIS JWH ZIMMER, INC. NA 1657230

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK MOST STEM DISTRACTOR: CATALOG# 510003707| LOT# 1627174