BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 52

    MDR report key: 2791946 · Received October 15, 2012

    Report

    Report Number
    1818910-2012-76573
    Event Type
    Injury
    Date Received
    October 15, 2012
    Date of Event
    February 16, 2015
    Report Date
    February 16, 2015
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    PK040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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.DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED.(B)(4)

    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. (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

    LITIGATION PAPERS ALLEGE THAT POSTOPERATIVELY, THE PATIENT SUFFERED PAIN, STIFFNESS, DISCOMFORT, AND WEAKNESS WHICH IN TURN NEGATIVELY AFFECTS HIS MOBILITY AND QUALITY OF LIFE. PATIENT WAS INJURED BY EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HIS BLOOD AND SUFFERS FROM ANXIETY ABOUT THE IMPLANT AND THE TOXICITY OF THE METAL IN HIS BODY.

    Description of Event or Problem · 1

    UPDATE 16 FEB 2015 - DER RCVD - ADDED DOR, SURGEON AND SALES REP DETAILS, PATIENT HEIGHT, WEIGHT AND DOB. ADDED ALL PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 52 ACETABULAR CUP HIP IMPLANT KWA DEPUY INTERNATIONAL 2949512

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other| R