BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MBT STEP WEDGE SZ2.5 15MM

    MDR report key: 3844241 · Received June 2, 2014

    Report

    Report Number
    1818910-2014-19927
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 7, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    LXH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    CONCLUSION AND JUSTIFICATION STATUS FOR MDR: DEPUY (B)(4) PACKAGING ENGINEERING EXAMINED THE COMPLAINT SAMPLE PRODUCT AND CONFIRMED THAT THERE IS WHITE DEBRIS ON THE PRODUCT. THE ROOT CAUSE IS PACKAGE DESIGN RELATED. NO CORRECTIVE ACTION TAKEN BECAUSE OF THE LOW FREQUENCY OF OCCURANCE OVER THE LAST FIVE YEARS. (B)(4) PACKAGING DEVELOPMENT WILL CONTINUE TO MONITOR FUTURE REPORTED EVENTS. 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    A WHITE DUSTY POWDER WAS FOUND ON THE SURFACE OF IMPLANT. THE ITEM HAD BEEN INTRODUCED INTO THE SURGICAL FIELD AND OPENED FOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322287 MBT STEP WEDGE SZ2.5 15MM KNEE STEP WEDGE LXH DEPUY ORTHOPAEDICS, INC. 1818910 Y4LEM1000

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other| R