BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 125378 · Received October 6, 1997

    Report

    Report Number
    1818910-1997-00204
    Event Type
    Injury
    Date Received
    October 6, 1997
    Date of Event
    August 12, 1997
    Manufacturer
    DEPUY ORTHOPAEDICS, INC
    Product Code
    JWH
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOGUE NO: 1485-61-025, LOT NO. 693740 CATALOGUE NO: 1488-07-000, LOT NO. 825790 CATALOGUE NO: 1988-35-000, LOT NO. 556920. THERE WAS NO REASON GIVEN FOR THE EXPLANTATION OF THE KNEE PRODUCTS. THE INVESTIGATION CONDUCTED FOUND NO WEAR ON ANY OF THE PRODUCTS. SINCE NO REASON WAS GIVEN FOR EXPLANTATION AND ALL PRODUCTS WERE FOUND IN SPECIFICATION, NO CONCLUSION CAN BE MADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * Implant * JWH DEPUY ORTHOPAEDICS, INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1