BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER PATIENT SPECIFIC INTRUMENT

    MDR report key: 2943966 · Received January 30, 2013

    Report

    Report Number
    3005718816-2013-00001
    Event Type
    Injury
    Date Received
    January 30, 2013
    Date of Event
    December 10, 2012
    Report Date
    January 2, 2013
    Manufacturer
    MATERIALISE NV
    Product Code
    MBH
    PMA / PMN Number
    K091263
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE INTERNAL DOCUMENTATION AND THE DEVICE DID NOT SHOW AN ANOMALY OR DEVIATION. A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT A TOTAL KNEE ARTHROPLASTY PROCEDURE UTILIZING ZIMMER PATIENT SPECIFIC INSTRUMENTS GUIDES. DIFFICULTY WITH THE POSITIONING OF THE GUIDES RESULTED IN RECUTS USING TRADITIONAL INSTRUMENTS. THIS RESULTED IN AN INCREASE IN SURGERY TIME OF 30 MINUTES. NO INJURY TO THE PT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40235 ZIMMER PATIENT SPECIFIC INTRUMENT MBH, JWH MBH MATERIALISE NV 00-5970-000-02 56538549

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Life Threatening