BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    865034

    MDR report key: 4874413 · Received June 29, 2015

    Report

    Report Number
    1818910-2015-24530
    Event Type
    Malfunction
    Date Received
    June 29, 2015
    Date of Event
    June 18, 2015
    Report Date
    June 18, 2015
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE SUBMITTED CUTTING GUIDE CONFIRMED ONE OF THE TWO SAW CAPTURES IS BROKEN. THE ROOT CAUSE IS BEING ATTRIBUTED TO PRODUCT WEAR OUT. BASED ON THE INVESTIGATION DETERMINATION OF WEAR OUT AS THE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. BASED ON THE DETERMINATION OF PRODUCT 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 (B)(4) SIGMA HP PAT RES GUIDE HAS BEEN DESIGNED AND DOES NOT CONTAIN SIMILAR BRIDGE WASHER TO BRIDGE FEATURES. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    THE SAW GUIDE ON THE LOBSTER CLAW BROKE DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418660 865034 KNEE INSTRUMENT/TRIAL LXH DEPUY ORTHOPAEDICS, INC. NB0003352

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR