BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACS POLY 20D 28 GR 3

    MDR report key: 367147 · Received December 19, 2001

    Report

    Report Number
    1818910-2001-00434
    Event Type
    Malfunction
    Date Received
    December 19, 2001
    Date of Event
    November 6, 2001
    Report Date
    December 19, 2001
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JDI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DOCTOR OPENED PART NUMBER 1115-28-025 (GROUP 3) ; LOT NUMBER VT7AC1005 - BASED ON THE EXPLANTED PRODUCT. DOCTOR THOUGHT EXPLANT WAS ENGRAVED GROUP 3 AND OPENED A GROUP 3 PRODUCT WHICH DID NOT FIT. OPENED A GROUP 2 - PART NUMBER 1115-27-025 AND PRODUCT FIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57631 ACS POLY 20D 28 GR 3 TOTAL HIP PROSTHESIS JDI DEPUY ORTHOPAEDICS, INC. NA VT7AC1005

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other| R