BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE SECTOR II CUP 52MM

    MDR report key: 3960595 · Received July 28, 2014

    Report

    Report Number
    1818910-2014-24246
    Event Type
    Injury
    Date Received
    July 28, 2014
    Date of Event
    July 7, 2014
    Report Date
    August 21, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.1818910
    Product Code
    KWA
    PMA / PMN Number
    PK073504
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    THIS PRODUCT WAS REPORTED IN ERROR. IT DID NOT CONTRIBUTE TO THE REPORTED EVENT AND IS BEING REJECTED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439269 PINNACLE SECTOR II CUP 52MM HIP ACETABULAR CUP KWA DEPUY ORTHOPAEDICS, INC.1818910 DV3EP1000

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention