BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER PATIENT SPECIFIC INSTRUMENT

    MDR report key: 2483423 · Received March 5, 2012

    Report

    Report Number
    3003998208-2012-00004
    Event Type
    Injury
    Date Received
    March 5, 2012
    Date of Event
    November 19, 2012
    Report Date
    February 8, 2012
    Manufacturer
    MATERIALISE NV
    Product Code
    MBH
    PMA / PMN Number
    K093533
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE INTERNAL DOCUMENTATION 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/OR THE DEVICE BE RETURNED FOR EVALUATION 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 REQUIRED THE SURGEON TO SWITCH TO TRADITIONAL INSTRUMENTATION. THIS RESULTED IN A DELAY DURING SURGERY OF 45 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER PATIENT SPECIFIC INSTRUMENT MBH, JWH MBH MATERIALISE NV 00-5970-000-03 56.525240

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Life Threatening