BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY PINNACLE SECTOR 50MM CUP

    MDR report key: 2233154 · Received September 2, 2011

    Report

    Report Number
    1818910-2011-17178
    Event Type
    Injury
    Date Received
    September 2, 2011
    Date of Event
    August 5, 2011
    Report Date
    March 20, 2026
    Manufacturer
    DEPUY WARSAW
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    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

    PATIENT WAS REVISED TO ADDRESS A SYNTHES SCREW THAT HAD BEEN PREVIOUSLY IMPLANTED DURING A RECONSTRUCTION OF THE POSTERIOR WALL BACKED OUT AND DAMAGED THE LINER. THE LINER WAS NO LONGER LOCKED INTO THE CUP. ADDITIONAL INFORMATION OBTAINED FROM THE SALES REP INDICATED THAT IT IS POSSIBLE THAT THE CUP WAS NOT POSITIONED PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY PINNACLE SECTOR 50MM CUP ACETABULAR CUP KWA DEPUY WARSAW ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention