BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SP*2 FEMORAL IMPACTOR

    MDR report key: 3842465 · Received June 2, 2014

    Report

    Report Number
    1818910-2014-19849
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 14, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, 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.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED DEVICES CONFIRMED THE REPORTED EVENT OF IMPACTOR DAMAGE/FRACTURE. PREVIOUS INVESTIGATIONS FOR DAMAGED SCREWS AND DAMAGED/FRACTURED IMPACTORS FOUND THE ROOT CAUSES ARE BEING ATTRIBUTED TO WEAR OUT AND POSSIBLE MISUSE. THE ROOT CAUSE IS ATTRIBUTED TO PRODUCT WEAR OUR AND POSSIBLE MISUSE BASED ON EXAMINATION OF THE RETURNED DEVICES. BASED ON PRODUCT WEAR OUT AND POSSIBLE MISUSE AS THE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. 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

    ONE FEMORAL IMPACTOR IS CHIPPED AND ONE FEMORAL IMPACTOR HAS COME APART. ONE SCREW IS STRIPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321015 SP*2 FEMORAL IMPACTOR KNEE INSTRUMENT/TRIAL LXH DEPUY ORTHOPAEDICS, INC. 1818910 NB6135

    Patients

    Seq Age Sex Outcome Treatment
    1