BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTER SLEEVES 12/14 +5

    MDR report key: 4263616 · Received November 19, 2014

    Report

    Report Number
    1818910-2014-32069
    Event Type
    Injury
    Date Received
    November 19, 2014
    Date of Event
    September 10, 2015
    Report Date
    October 22, 2014
    Manufacturer
    DEPUY INTL., LTD. - 8010379
    Product Code
    KWA
    PMA / PMN Number
    PK040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). UPDATE 1/12/16: MEDICAL RECORDS RECEIVED. MEDICAL RECORDS REVIEWED FOR MDR REPORTABILITY. PRIMARY SURGICAL REPORT NOTED BLOOD LOSS OF 800CC WITH NO DOCUMENTED COMPLICATIONS AND WAS DOCUMENTED AS NOT REPLACED. THE REVISION SURGICAL REPORT NOTED METALLOSIS FLUID, TRUNNIONOSIS AND AN EFFUSION. STICKER SHEET WAS INCLUDED. DOR UPDATED. PART/LOT UPDATED. THE COMPLAINT WAS UPDATED ON: JAN 29, 2016. DEGENERATIVE ARTHRITIS. ADAPTER SLEEVES 12/14 +5. FDA CODE: KWA. PART NUMBER: 999800315. LOT NUMBER: 2814163. (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

    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. REF. WWCAPA (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. FOR ANY PRODUCT INFORMATION RECEIVED. THIS COMPLAINT IS THE SUBJECT OF LITIGATION OR A LEGAL CLAIM AND CURRENTLY COMPLETE PRODUCT DETAIL IS NOT AVAILABLE AT THIS TIME. A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    UPDATE 1/12/16 MEDICAL RECORDS RECEIVED. MEDICAL RECORDS REVIEWED FOR MDR REPORTABILITY. PRIMARY SURGICAL REPORT NOTED BLOOD LOSS OF 800CC WITH NO DOCUMENTED COMPLICATIONS AND WAS DOCUMENTED AS NOT REPLACED. THE REVISION SURGICAL REPORT NOTED METALLOSIS FLUID, TRUNNIONOSIS AND AN EFFUSION. STICKER SHEET WAS INCLUDED. DOR UPDATED. PART/LOT UPDATED. THE COMPLAINT WAS UPDATED ON: JAN 29, 2016.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE PAIN, DISCOMFORT, SORENESS, MALAISE, SWELLING, IMMOBILIZATION AND BOTH ACUTE LOCALIZED DAMAGE TO TISSUE AND/OR BONE SURROUNDING THE ACETABULUM, AND ELEVATED METAL ION LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749532 ADAPTER SLEEVES 12/14 +5 HIP FEMORAL STEM/SLEEVE KWA DEPUY INTL., LTD. - 8010379 2814163

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other