BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER PATIENT SPECIFIC INSTRUMENT

    MDR report key: 2236986 · Received August 31, 2011

    Report

    Report Number
    3003998208-2011-00002
    Event Type
    Injury
    Date Received
    August 31, 2011
    Date of Event
    August 2, 2011
    Report Date
    August 2, 2011
    Manufacturer
    MATERIALISE N.V.
    Product Code
    MBH
    PMA / PMN Number
    K093533
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRE-SURGICAL PLAN WITH APPROXIMATELY 1 MM NOTCHING WAS APPROVED BY SURGEON. THE DEVICE MET PRODUCT SPECIFICATIONS AND A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE SURGEON REPORTED AN ANTERIOR RESECTION WHICH CREATED A NOTCH AT THE ANTERIOR SIDE OF THE FEMUR. THE EXTENT OF THE NOTCH WAS VISUALLY ESTIMATED TO BE 2-3 MM. DUE TO THE MAGNITUDE OF THIS NOTCH, THE SURGEON DECIDED TO USE A STEMMED FEMUR IMPLANT INSTEAD OF THE REGULAR FEMUR IMPLANT. THE SURGERY TIME WAS EXTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER PATIENT SPECIFIC INSTRUMENT MBH,JWH MBH MATERIALISE N.V. 00-5970-000-02 11.672.461

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention