BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFC*CALIBRATED PAT CUT GDE

    MDR report key: 4251910 · Received November 14, 2014

    Report

    Report Number
    1818910-2014-31711
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    November 11, 2014
    Report Date
    November 11, 2014
    Manufacturer
    DEPUY-RAYNHAM,A DIV. OF DEPUY ORTHOPAEDICS 1219655
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE SUBMITTED CUTTING GUIDE CONFIRMED ONE OF THE TWO SAW CAPTURES IS BROKEN. INITIAL REPORTS STATES ALL PIECES WERE RETRIEVED. THE LOT CODE OF J0311 INDICATES A VENDOR MANUFACTURE DATE OF MARCH 2011. THE ROOT CAUSE IS BEING ATTRIBUTED TO PRODUCT WEAR OUT BASED ON THE OVERALL CONDITION OF THE RETURNED DEVICE. BASED ON THE INVESTIGATION DETERMINATION OF WEAR OUT AS THE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. ALTHOUGH THIS INVESTIGATION DID NOT ESTABLISH THE NEED FOR CORRECTIVE ACTION, A NEW PATELLA RESECTION GUIDE 950501121 SIGMA HP PAT RES GUIDE HAS BEEN DESIGNED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    DURING SURGERY FOR A BILATERAL TOTAL KNEE REPLACEMENT, THE PATELLA CUTTING CLAMP BROKE ON THE LEFT KNEE. ALL PIECES WERE RETRIEVED AND THERE WAS NO DELAY IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737773 PFC*CALIBRATED PAT CUT GDE KNEE INSTRUMENTS LXH DEPUY-RAYNHAM,A DIV. OF DEPUY ORTHOPAEDICS 1219655 J0311

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR