BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER PATIENT SPECIFIC INSTRUMENT

    MDR report key: 2329660 · Received October 21, 2011

    Report

    Report Number
    3003998208-2011-00007
    Event Type
    Malfunction
    Date Received
    October 21, 2011
    Date of Event
    April 7, 2011
    Report Date
    April 21, 2011
    Manufacturer
    MATERIALISE N.V.
    Product Code
    MBH
    PMA / PMN Number
    K093533
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 INFO PROVIDED. SHOULD ADD'L INFO BECOME AVAILABLE AND/OR THE DEVICE BE RETURNED FOR EVAL AND AN INVESTIGATION RESULT BE AVAILABLE THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED. THIS REPORTABLE EVENT WAS IDENTIFIED ON (B)(4), 2011 AS PART OF A RETROSPECTIVE REVIEW IN REPLY TO THE FDA (B)(4).

    Description of Event or Problem · 1

    A PT SPECIFIC GUIDE WAS USED TO PLACE A TOTAL KNEE REPLACEMENT IMPLANT. THE GUIDE FIT WAS PERFECT, BUT THE ANTERIOR CUT SHOWED A NOTCH AT THE PROXIMAL SIDE WHICH WAS DISCOVERED DURING SURGERY.

    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 56502359

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR