BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN DEPUY ASR IMPLANTS

    MDR report key: 1940234 · Received December 23, 2010

    Report

    Report Number
    1818910-2010-09494
    Event Type
    Malfunction
    Date Received
    December 23, 2010
    Report Date
    November 23, 2010
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    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

    THIS IS A DUPLICATE OF REPORT NUMBER 1818910-2010-09972. DEPUY CONSIDERS THIS COMPLAINT CLOSED.

    Description of Event or Problem · 1

    RECOMMENDED ASR REVISION - LEFT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY ASR IMPLANTS 87KWA KWA DEPUY INTERNATIONAL, LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention