BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTER SLEEVES 12/14 +5

    MDR report key: 2881303 · Received December 20, 2012

    Report

    Report Number
    1818910-2012-28467
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    June 21, 2011
    Report Date
    December 7, 2012
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS PAIN AND ELEVATED METAL ION LEVELS. (B)(6) 2012 - PATIENT'S OPERATIVE REPORTS RECEIVED. RECORDS INDICATE UPON REVISION MILD CORROSION WAS NOTED AROUND THE MORSE TAPER.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS PAIN AND ELEVATED METAL ION LEVELS. UPDATE PATIENTS OPERATIVE REPORTS RECEIVED. RECORDS INDICATE UPON REVISION MILD CORROSION WAS NOTED AROUND THE MORSE TAPER. THE STEM AND SLEEVE WERE ADDED TO THE PRODUCT PAGES AND THE COMPLAINT RE-OPENED. UPDATE LITIGATION ALLEGED THE ASR HIP WAS EXPLANTED DUE TO PAIN, SWELLING, INFLAMMATION, DAMAGE TO SURROUNDING BONE AND TISSUE, A LACK OF MOBILITY AND OTHER INJURIES DUE TO THE EXCESSIVE LEVELS OF CHROMIUM AND COBALT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADAPTER SLEEVES 12/14 +5 SLEEVE KWA DEPUY INTERNATIONAL 2371801

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR