BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MBT REV TIBIAL VIEW PLT SZ2.5

    MDR report key: 6013589 · Received October 10, 2016

    Report

    Report Number
    1818910-2016-28959
    Event Type
    Malfunction
    Date Received
    October 10, 2016
    Date of Event
    October 3, 2016
    Report Date
    October 3, 2016
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    ADDITIONAL NARRATIVE: EXAMINATION OF THE RETURNED MBT REV TIBIAL VIEW PLATE CONFIRMED THE REPORTED EVENT. THE ROOT CAUSE IS ATTRIBUTED TO PRODUCT WEAR OUT; HOWEVER, MISUSE (POSSIBLY THROUGH USER ERROR) CANNOT BE RULED OUT. THE OVERALL CONDITION OF THE INSTRUMENT INDICATES MULTIPLE USAGES. THE DEVICE EXHIBITS BURNISHING WEAR INDICATED OF EXTENDED USAGE. THE DEVICE ALSO EXHIBITS A SHADE OF YELLOW INDICATING IT HAS BEEN SUBJECTED TO NUMEROUS DECONTAMINATION PROCEDURES. THE SURGICAL TECHNIQUE WAS REVIEWED BY PRODUCT DEVELOPMENT AND MARKETING TO TRY TO UNDERSTAND THE POSSIBILITY THAT THE VIEW PLATE MAY BE ATTACHED TO THE IMPACTOR AND BROACH DURING IMPACTION, RESULTING IN THE NOTED FRACTURES OF THE VIEW PLATES. THIS THEORY COULD NOT BE CONFIRMED NOR RULED OUT, THEREFORE MARKETING AGREED TO RELEASE A SALES MAIL TO THE FIELD (RELEASED ON 6/6/2011) INSTRUCTING THE PROPER USAGES (VIEW PLATE NOT ATTACHED , JUST USED AS A VISUAL AIDE) TO MITIGATE THIS RISK ASSOCIATED WITH THIS POSSIBILITY. BASED ON THE INVESTIGATION DETERMINATION OF PRODUCT WEAR OUT AS THE ROOT CAUSE NO CORRECTIVE ACTION IS BEING TAKEN. MONITOR THROUGH (B)(4). 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.

    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

    THE MBT REVISION TRIAL SIZER BROKE WHILE TRIALING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666013 MBT REV TIBIAL VIEW PLT SZ2.5 KNEE INSTRUMENTS LXH DEPUY ORTHOPAEDICS, INC. 1818910 SO2010962

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR