BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGLED ACET INSERTR

    MDR report key: 4271998 · Received November 24, 2014

    Report

    Report Number
    1818910-2014-32346
    Event Type
    Malfunction
    Date Received
    November 24, 2014
    Date of Event
    November 11, 2014
    Report Date
    November 11, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED DEVICE CONFIRMS THE PLASTIC LOCKING SLIDE HAS BROKEN. PREVIOUSLY A CORRECTIVE ACTION WAS IDENTIFIED FOR THIS FAILURE MODE WHEREBY A DESIGN CHANGE WAS IMPLEMENTED AND ROUTED ON ECO-193427 (DWG-106984) IN 2007 IN ORDER TO STRENGTHEN THE LOCKING CATCH. THE DESIGN VERIFICATION WAS COMPLETED AND ROUTED ON DVA-101743-FDE CONTAINING THE FMEA AND RISK MANAGEMENT REPORT. THE RISK MANAGEMENT REPORT (RISK MANAGEMENT SPARE PARTS REV A) CONCLUDED THAT THERE ARE NO OUTSTANDING ACTIONS IDENTIFIED. THIS PRODUCT WAS MANUFACTURED TO THE REVISED DESIGN HOWEVER NO TREND IS IDENTIFIED AT THE CURRENT TIME. CONTINUED POST MARKET SURVEILLANCE WILL BE CARRIED OUT PER SEP-419 UNDER THE POST MARKET SURVEILLANCE PLAN. 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 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

    THE PLASTIC PIECE, WHICH LOCKS ON ANGLED CUP IMPACTOR CRACKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760571 ANGLED ACET INSERTR HIP INSTRUMENT/TRIAL LXH DEPUY ORTHOPAEDICS, INC. P10332001

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR