BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER PATIENT SPECIFIC INTRUMENT

    MDR report key: 2943967 · Received January 30, 2013

    Report

    Report Number
    3003998208-2013-00001
    Event Type
    Injury
    Date Received
    January 30, 2013
    Date of Event
    November 28, 2012
    Report Date
    January 2, 2013
    Manufacturer
    MATERIALISE N.V.
    Product Code
    MBH
    PMA / PMN Number
    K091263
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE NARRATIVE OF THE EVENT PROVIDED BY THE COMPLAINANT SHOWS THAT THE PROVIDED SURGICAL TECHNIQUE WAS NOT FOLLOWED COMPLETELY. IN PARTICULAR, A DESCRIBED STEP TO VERIFY THE ABSENCE OF NOTCHING PRIOR TO CUTTING WAS SKIPPED. THEREFORE, A FAILURE TO FOLLOW THE INSTRUCTIONS IS CONSIDERED TO BE PART OF THE INVESTIGATION CONCLUSION. AN EVALUATION OF THE PT SPECIFIC DESIGN SPECIFICATIONS DID NOT PROVIDE A POTENTIAL CAUSE 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

    THE ANTERIOR CUT TO PLACE THE FEMORAL IMPLANT WAS PERFORMED WITH A CUT BLOCK OF WHICH THE PLACEMENT WAS GUIDED BY THE DEVICE. A NOTCH OF 5 MM IN THE ANTERIOR CUT FOR THE FEMUR WAS NOTICED DURING SURGERY AFTER THE CUT WAS PERFORMED. NO INFORMATION WAS RECEIVED THAT INDICATES A REVISION SURGERY IS PLANNED OR PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40553 ZIMMER PATIENT SPECIFIC INTRUMENT MBH, JWH MBH MATERIALISE N.V. 00-5970-000-02 56537794

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR