BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 54

    MDR report key: 2071603 · Received April 15, 2011

    Report

    Report Number
    1818910-2011-06645
    Event Type
    Injury
    Date Received
    April 15, 2011
    Report Date
    March 18, 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
    VA, 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

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    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

    BILATERAL PATIENT LITIGATION PAPERS ALLEGE AFTER HER SURGERIES, PATIENT BEGAN TO EXPERIENCE SEVERE PAIN IN EACH HIP. IT IS FURTHER ALLEGED THIS CONDITION HAS NOT DISSIPATED WITH TIME. (B)(6) 2011 - THE SALES REP HAS REPORTED THE REVISION FOR THE RIGHT SIDE. PATIENT WAS REVISED TO ADDRESS ACETABULAR CUP LOOSENING.

    Description of Event or Problem · 1

    BILATERAL PATIENT: LITIGATION PAPERS ALLEGE AFTER HER SURGERIES, PATIENT BEGAN TO EXPERIENCE SEVERE PAIN IN EACH HIP. IT IS FURTHER ALLEGED THIS CONDITION HAS NOT DISSIPATED WITH TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 54 NONE KWA DEPUY INTERNATIONAL, LTD. NA 2297151

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention