BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER PATIENT SPECIFIC INSTRUMENT

    MDR report key: 2478919 · Received March 1, 2012

    Report

    Report Number
    3003998208-2012-00002
    Event Type
    Injury
    Date Received
    March 1, 2012
    Date of Event
    December 2, 2011
    Report Date
    December 19, 2011
    Manufacturer
    MATERIALISE NV
    Product Code
    MBH
    PMA / PMN Number
    K093533
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE INTERNAL DOCUMENTATION SHOW THAT THE PIN GUIDE HAS BEEN DESIGNED ACCORDING TO THE TECHNICAL SPECS OF THE PSI PRODUCT LINE. THE CAUSE OF THIS CLINICAL EVENT IS FOUND IN THE USE OF AN MOBILE BEARING TIBIA IMPLANT BY THE SURGEON WHEREAS THE INTENDED USE OF THE ZIMMER PT SPECIFIC INSTRUMENTS PROVIDED IN THE IFU ONLY INCLUDES ZIMMER FIXED BEARING TIBIA IMPLANTS. THEREFORE IT IS CONCLUDED THAT USER ERROR LIES AT THE ROOT OF THE EVENT. SHOULD ADD'L INFO BECOME AVAILABLE OR AN INVESTIGATION RESULT BECOME AVAILABLE THAT CHANGES THIS ASSESSMENT OR IF THE CLINICAL STATUS OF THE PT REGARDING THE EVENT WOULD CHANGE, AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED.

    Description of Event or Problem · 1

    A TOTAL KNEE REPLACEMENT WAS PERFORMED USING THE DEVICE TO GUIDE THE CUTS. THE SURGEON REPORTED A PERFECT POSITION AND STABILITY OF THE GUIDES. POST-OPERATIVE X-RAYS SHOWED THE TIBIA IS IN NORMOAXIAL AND IN CONSIDERABLE VARUS. A REVISION SURGERY WAS PERFORMED ON (B)(6), 2012 DURING WHICH THE POLYETHYLENE INSERT WAS REPLACED FOR THE WIDEST THICKNESS. AFTER THE REVISION SURGERY, THE PT'S KNEE IS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER PATIENT SPECIFIC INSTRUMENT MBH, JWH MBH MATERIALISE NV 00-5970-000-01 11.701944

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other