BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTER SLEEVES 12/14 +5

    MDR report key: 3141097 · Received June 3, 2013

    Report

    Report Number
    1818910-2013-17990
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    December 7, 2012
    Report Date
    May 6, 2013
    Manufacturer
    DEPUY INTL., LTD. - 8010379
    Product Code
    KWA
    PMA / PMN Number
    PK040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN AUGUST 2010, AND THE ASR PRODUCT CODES ARE NOW CONSIDERED INACTIVE. FURTHER INVESTIGATION OF THIS INDIVIDUAL INCIDENT WILL NOT BE UNDERTAKEN, AS THERE IS AN ONGOING INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS. REF. (B)(4). DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PATIENT'S REVISION OPERATIVE RECORDS WERE RECEIVED. RECORDS INDICATE THE PATIENT WAS REVISED TO ADDRESS INCREASED METAL ION LEVELS. UPON REVISION SYNOVITIS AND GRAY COLORED FLUID WERE FOUND IN THE HIP. ALSO NOTED, CORROSION WAS FOUND ON THE FEMORAL NECK. THE FEMORAL STEM AND SLEEVE WERE ADDED TO THE COMPLAINT AND THE COMPLAINT WAS RE-OPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243156 ADAPTER SLEEVES 12/14 +5 SLEEVE KWA DEPUY INTL., LTD. - 8010379 2425843

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR