BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER PATIENT SPECIFIC INSTRUMENT

    MDR report key: 2624619 · Received June 13, 2012

    Report

    Report Number
    3003998208-2012-00010
    Event Type
    Injury
    Date Received
    June 13, 2012
    Date of Event
    May 7, 2012
    Report Date
    May 18, 2012
    Manufacturer
    MATERIALISE N.V.
    Product Code
    MBH
    PMA / PMN Number
    K093533
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    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 PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY PROCEDURE UTILIZING ZIMMER PATIENT SPECIFIC INSTRUMENTS GUIDES. DIFFICULTY WITH THE POSITIONING OF THE GUIDES REQUIRED THE SURGEON TO DO RE-CUTS IN ORDER TO ACHIEVE BALANCE. THIS RESULTED IN A DELAY DURING SURGERY OF 30 MIN.

    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 56531126

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Life Threatening