BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 60

    MDR report key: 2231808 · Received September 1, 2011

    Report

    Report Number
    1818910-2011-17017
    Event Type
    Injury
    Date Received
    September 1, 2011
    Report Date
    August 3, 2011
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED: BRAND NAME, COMMON DEVICE NAME/DEVICE PRODUCT CODE, CATALOG #/LOT #, 510K, MANUFACTURE DATE. THIS INVESTIGATION IS STILL CONSIDERED CLOSED.

    Additional Manufacturer Narrative · 1

    THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN (B)(4) 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: BILATERAL PATIENT WAS IMPLANTED WITH A DEPUY ASR HIP IMPLANT ON HIS RIGHT SIDE ON (B)(6), 2008, AND ON HIS LEFT SIDE ON (B)(6), 2008. AFTER THE SURGERIES, PATIENT EXPERIENCED SEVERE PAIN AND DISCOMFORT, EXPRESSED SYMPTOMS INDICATING A LOOSE IMPLANT, AND WILL ULTIMATELY UNDERGO REVISION SURGERY. HE HAS ALSO SUFFERED LOSS OF MUSCLE MASS, LOSS OF SLEEP, HAS DIFFICULTY MAINTAINING HIS BALANCE, AND WALKS WITH A LIMP. IN ADDITION, BLOOD RESULTS INDICATE HE HAS ELEVATED LEVELS OF COBALT AND CHROMIUM IN HIS BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 60 ACETABULAR SHELL KWA DEPUY INTERNATIONAL 2228498

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention