BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HP MBT CEM PUNCH SZ 2-3

    MDR report key: 4890716 · Received July 6, 2015

    Report

    Report Number
    1818910-2015-24991
    Event Type
    Malfunction
    Date Received
    July 6, 2015
    Date of Event
    June 19, 2015
    Report Date
    July 14, 2015
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED DEVICE CONFIRMS ONE OF THE TWO TABS IS FRACTURED. THE OTHER TAB SHOWS SIGNS OF WEAR. THE ROOT CAUSE IS ATTRIBUTED TO DESIGN. (B)(4) AND (B)(4) WERE INITIATED TO ADDRESS THE TAB FRACTURE. THE UPDATED DESIGN WILL BE RELEASED WITH A NEW PRODUCT CODE HOWEVER, NO PRODUCTS HAVE BEEN RELEASED FOR DISTRIBUTION. 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 UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THE 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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ONE LOCATION TAB OF THE IMPACTOR PUNCH LOCATION AREA OF THE CEMENTED PUNCH SIZE 2-3 HAS SNAPPED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435192 HP MBT CEM PUNCH SZ 2-3 KNEE INSTRUMENT/TRIAL LXH DEPUY ORTHOPAEDICS, INC. B1207

    Patients

    Seq Age Sex Outcome Treatment
    1