BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTER SLEEVES 12/14 +8

    MDR report key: 3780771 · Received April 30, 2014

    Report

    Report Number
    1818910-2014-17745
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    August 23, 2013
    Report Date
    April 8, 2014
    Manufacturer
    DEPUY INTL., LTD. - 8010379
    Product Code
    KWA
    PMA / PMN Number
    PK040627
    Removal / Correction Number
    Z-1749/1816-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. 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. 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

    LITIGATION PAPERS ALLEGE PAIN AND ELEVATED METAL ION LEVELS. (B(4) 2013 - PLAINTIFF¿S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED DOB AND DOI INFORMATION. PATIENT STICKER SHEET WAS PROVIDED AND PART AND LOT WERE UPDATED. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. (B)(4) 2014 - SALES REP REPORTED REVISION SURGERY. PATIENT WAS REVISED TO ADDRESS HIGH METAL IONS, METAL WEAR AND A PSEUDOTUMOR. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION. THIS COMPLAINT WAS UPDATED ON: (B)(4) 2014. UPDATE: (B)(4) 2014 - MEDICAL RECORDS RECEIVED. PATIENT WAS REVISED TO ADDRESS PERIPROSTHETIC FRACTURE, DISLOCATION, A LARGE FLUID-FILLED SAC THAT WAS BLACKISH-GREENISH IN COLOR, CONSISTENT WITH METALLOSIS AND PSEUDOTUMOR, AND CORROSION. THE ADAPTER SLEEVE AND FEMORAL STEM ARE NOW BEING ADDED TO THE COMPLAINT. THIS COMPLAINT WAS UPDATED ON: (B)(4) 20114.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260260 ADAPTER SLEEVES 12/14 +8 HIP OTHER IMPLANT KWA DEPUY INTL., LTD. - 8010379 2302055

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR