BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIN SECTOR II ACE CUP 60MM

    MDR report key: 405723 · Received July 19, 2002

    Report

    Report Number
    1818910-2002-00393
    Event Type
    Injury
    Date Received
    July 19, 2002
    Date of Event
    June 21, 2002
    Report Date
    July 19, 2002
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE 1217-22-060 CUP WAS IMPLANTED AND THE SURGEON TRIED A 1219-28-460 LINER. IT WOULD NOT SEAT. HE TRIED A 1219-28-160 LINER AND IT WOULD NOT SEAT. HE CHANGED THE CUP TO A 1217-22-062 AND USED A 1219-28-462 LINER. THE PROCEDURE WAS EXTENDED 35 MINUTES..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIN SECTOR II ACE CUP 60MM TOTAL HIP PROSTHESIS LPH DEPUY ORTHOPAEDICS, INC. NA V86DJ1004

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention