BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER PATIENT SPECIFIC INSTRUMENT

    MDR report key: 4758559 · Received May 5, 2015

    Report

    Report Number
    3005718816-2015-00003
    Event Type
    Injury
    Date Received
    May 5, 2015
    Date of Event
    May 19, 2014
    Report Date
    April 10, 2015
    Manufacturer
    MATERIALISE USA LLC.
    Product Code
    HSX
    PMA / PMN Number
    K112301
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER RE-EVALUATION OF THE SEGMENTATION AN OVERSEGMENTATION IN THE MEDIAL TIBIA PLATEAT REGION AND OVERSEGMENTATION IN THE CORTICAL BONE REGION WAS FOUND. THOSE INACCURACIES POSSIBLY HAD AN IMPACT ON THE TIBIA GRADE FIT AND COULD HAVE CAUSED AN INCORRECT TIBIA GUIDE POSITION. THIS POSSIBLY CONTRIBUTED TO AN INCORRECT TIBIA RESECTION LEVEL. THEREFORE THIS INACCURACY COULD HAVE CONTRIBUTED TO THE ERROR THAT THE SURGEON IS STATING, NAMELY THAT THE TIBIA GUIDE CUT LESS THAN THE PLANNED AMOUNT. FOR THE DISCREPANCIES ON THE FEMUR THE INVESTIGATION DID NOT IDENTIFY A POTENTIAL ROOT CAUSE. NOTE THAT THE INVESTIGATION ONLY INVESTIGATED THE GUIDES AND DOES NOT INCLUDE OTHER POTENTIAL ROOT CAUSES SUCH AS THE STEPS PERFORMED AFTER USING THE GUIDES NOR THE PLACEMENT OF THE IMPLANT NOR ANY PHYSICAL CONDITION THAT COULD CAUSE IMPLANT LOOSENING. THE EVENT INFORMATION DOES NOT CONFIRM THE FEMORAL IMPLANT LOOSENING IS CAUSED BY THE GUIDES.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE INTERNAL DOCUMENTATION IS IN PROGRESS WHICH HAS NOT YET RESULTED IN A ROOT CAUSE FOR THE EVENT. AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED AS SOON AS THE INVESTIGATION IS TERMINATED.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT UNICOMPARTMENTAL KNEE REPLACEMENT USING ZIMMER PATIENT SPECIFIC INSTRUMENTS. IT WAS REPORTED THAT THE TIBIAL CUT GUIDE CUT LESS THAN THE PLANNED AMOUNT CAUSING THE SURGEON TO RECUT THE TIBIA TWICE. ALSO THE TIBIA WAS SIZED INCORRECTLY. FEMORAL CUT GUIDE CAUSED THE FEMUR TO BE CUT MEDICALLY INSTEAD OF PARALLEL TO THE TIBIA. THE FEMORAL PLAN WAS ALSO INACCURATE AS FAR AS SIZING. THERE WAS NO BLOOD LOSS REPORTED. A DELAY OF 60 MINUTES WAS REPORTED. PATIENT UNDERWENT REVISION SURGERY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATES THE REVISION SURGERY WAS REQUIRED BECAUSE OF FEMORAL IMPLANT LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295719 ZIMMER PATIENT SPECIFIC INSTRUMENT HSX MATERIALISE USA LLC. 00-5970-000-04 56590363

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention