BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACS POLY W/ LIP 28 GR2

    MDR report key: 254444 · Received December 16, 1999

    Report

    Report Number
    1818910-1999-00253
    Event Type
    Injury
    Date Received
    December 16, 1999
    Date of Event
    December 9, 1999
    Report Date
    December 16, 1999
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JDI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS PT HAS BEEN REVISED FOR THE SECOND ACS LINER FAILURE (SEE W94-0025). PATIENTS HEIGHT IS 5'4".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACS POLY W/ LIP 28 GR2 Implant TOTAL HIP PROSTHESIS JDI DEPUY ORTHOPAEDICS, INC. NA 813540013

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention