BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 56

    MDR report key: 1984364 · Received January 27, 2011

    Report

    Report Number
    1818910-2011-01151
    Event Type
    Injury
    Date Received
    January 27, 2011
    Date of Event
    December 28, 2010
    Report Date
    March 6, 2026
    Manufacturer
    DEPUY INTL., LTD.
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT STATES: LITIGATION PAPERS ALLEGE THE PATIENT WAS ADVISED THAT TEST RESULTS SHOWED TOXIC LEVELS OF COBALT AND CHROMIUM. ADDITIONAL EVALUATION IS BEING PERFORMED TO DETERMINE WHEN, AND IF, REVISION SURGERY CAN BE PERFORMED. DOI: (B)(6) 2008 - NO REPORTED REVISION (RIGHT SIDE). **UPDATE** (B)(6) 2011- THE SALES REP REPORTED THE REVISION SURGERY. THE PATIENT WAS REVISED TO ADDRESS ACETABULAR LOOSENING AND BLACK TISSUE STAINING. DOR: (B)(6) 2011; UPDATED THE PART/LOT INFORMATION. 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.

    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.

    Description of Event or Problem · 1

    PT REVISED FOR HIGH ION LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 56 87KWA KWA DEPUY INTL., LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention