BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER PATIENT SPECIFIC INSTRUMENT

    MDR report key: 2314532 · Received October 21, 2011

    Report

    Report Number
    3003998208-2011-00003
    Event Type
    Injury
    Date Received
    October 21, 2011
    Date of Event
    September 22, 2010
    Report Date
    September 27, 2010
    Manufacturer
    MATERIALISE N.V.
    Product Code
    MBH
    PMA / PMN Number
    K093533
    Adverse Event
    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT A TOTAL KNEE ARTHROPLASTY PROCEDURE UTILIZING ZIMMER PT SPECIFIC INSTRUMENTS GUIDES ON (B) (6) 2010. DIFFICULTY WITH THE FLEXION ANGLE RESULTED IN A DELAY OF 45 MINUTES. EVENT IS BEING REPORTED AS A DELAY IN THE PROCEDURE WAS INDICATED; NO PRODUCT NON-CONFORMANCES WERE IDENTIFIED.

    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 56503030

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention