BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR IMP 54

    MDR report key: 1962319 · Received January 7, 2011

    Report

    Report Number
    1818910-2010-10124
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    December 6, 2010
    Report Date
    December 10, 2010
    Manufacturer
    DEPUY INTL., LTD.
    Product Code
    KWA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO 510(K) NUMBER PROVIDED BECAUSE THIS IMPLANT IS SOLD INTERNATIONALLY WITH DIFFERENT INDICATIONS FOR USE; IT IS CURRENTLY SOLD IN THE US UNDER A DIFFERENT PART NUMBER. 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

    ON (B)(6) 2010, IT BECAME NECESSARY TO REVISE THE PT BECAUSE OF ACETABULUM MOBILIZATION WITH SUBLUXATION IN COMPARISON WITH THE FEMORAL HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR IMP 54 TOTAL HIP REPLACEMENT KWA DEPUY INTL., LTD. NA 2409590

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention