BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 54

    MDR report key: 2122852 · Received June 3, 2011

    Report

    Report Number
    1818910-2011-09932
    Event Type
    Injury
    Date Received
    June 3, 2011
    Report Date
    May 6, 2011
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    K040627
    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

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    PLAINTIFF'S PRELIMINARY DISCLOSURE FORM WAS RECEIVED WHICH IDENTIFIED PART/LOT INFORMATION. DEPUY STILL 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

    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, PATIENT HAS SUFFERED AND CONTINUES TO SUFFER BOTH INJURIES AND DAMAGES, INCLUDING BUT NO LIMITED TO: PAST, PRESENT AND FUTURE PHYSICAL AND MENTAL PAIN AND SUFFERING; AND PAST, PRESENT AND FUTURE MEDICAL, HOSPITAL, REHABILITATIVE AND PHARMACEUTICAL EXPENSES, LOST WAGES, AND OTHER RELATED DAMAGES. IT IS FURTHER ALLEGED THAT AFTER IMPLANTATION, PATIENT BEGAN EXPERIENCING SIGNIFICANT PAIN, CONSTANT IRRITATION, AND DISCOMFORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 54 TOTAL HIP PROSTHESIS KWA DEPUY INTERNATIONAL, LTD. NA 2153975

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention