BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER PATIENT SPECIFIC INSTRUMENT

    MDR report key: 2314531 · Received October 21, 2011

    Report

    Report Number
    3003998208-2011-00008
    Event Type
    Injury
    Date Received
    October 21, 2011
    Date of Event
    November 11, 2010
    Report Date
    December 9, 2010
    Manufacturer
    MATERIALISE N.V.
    Product Code
    MBH
    PMA / PMN Number
    K093533
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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)(6) 2011 AS PART OF A RETROSPECTIVE REVIEW IN REPLY TO (B)(6).

    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 POSITIONING OF THE GUIDES REQUIRED THE SURGEON TO SWITCH TO TRADITIONAL INSTRUMENTATION. THIS RESULTED IN A DELAY OF 1.5 H. 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. 00-5970-000-01 10.07447R

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention