BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 62

    MDR report key: 1903198 · Received November 12, 2010

    Report

    Report Number
    1818910-2010-08188
    Event Type
    Injury
    Date Received
    November 12, 2010
    Date of Event
    October 15, 2010
    Report Date
    October 15, 2010
    Manufacturer
    DEPUY INTL INC
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER
    Health Professional
    Yes

    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.

    Description of Event or Problem · 1

    PT REVISED FOR PAIN AND LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 62 87 KWA KWA DEPUY INTL INC NA 2159205

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention