BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGMA HP FEM NOTCH IMPACTOR

    MDR report key: 3933829 · Received July 15, 2014

    Report

    Report Number
    1818910-2014-23362
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    July 14, 2014
    Report Date
    July 14, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED DEVICE CONFIRMS THE REPORTED EVENT OF IMPACTOR BREAKAGE. THE ISSUE OF BREAKAGE OF RADEL HANDLES THAT ARE IMPACTED HAVE NOW BEEN REVIEWED BY THE CAPA REVIEW BOARD AND WAS IDENTIFIED FOR FURTHER ACTION. DATA REVIEW NO. DR-000714 WAS RAISED FOR FURTHER INVESTIGATION, TO INCLUDE REFERENCE TO DATA REVIEW ACTIVITY NO. DRA-001725. THE DRA DATA SHOWED THAT THERE IS NO SYSTEMIC FAILURE OF EXTRUDED RADEL AS A MATERIAL FOR USE IN INSTRUMENTS, AND THAT THE COMPLAINTS PERTAINING TO THIS FAILURE MODE FALL UNDER THE 2% THRESHOLD AGREED AT CAPA REVIEW BOARD. THE ROOT CAUSE IS ATTRIBUTED TO PRODUCT WEAR OUT BASED ON THE OVERALL CONDITION OF THE IMPACTOR. BASED ON THE ROOT CAUSE OF PRODUCT WEAR OUT, CORRECTIVE ACTION IS NOT NEEDED. 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.

    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

    TIP OF THE FEMORAL IMPACTOR BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412693 SIGMA HP FEM NOTCH IMPACTOR KNEE INSTRUMENT/TRIAL LXH DEPUY ORTHOPAEDICS, INC. J0809

    Patients

    Seq Age Sex Outcome Treatment
    1