BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FMRL PS OPEN INTL LT

    MDR report key: 9681895 · Received February 6, 2020

    Report

    Report Number
    MW5092836
    Event Type
    Injury
    Date Received
    February 6, 2020
    Date of Event
    November 22, 2019
    Report Date
    February 4, 2020
    Manufacturer
    BIOMET INC.
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PREVIOUSLY HAD HIS TOTAL KNEE DONE, REDONE BY DR (B)(6) ON (B)(6) 2019. DR (B)(6) OP NOTE DIAGNOSIS IS "FAILED LEFT TOTAL KNEE ARTHROPLASTY WITH CHRONIC PAIN AND INSTABILITY FROM ASEPTIC LOOSENING AND POLY-WEAR." HIS (B)(6) 2019 OFFICE NOTE SAYS THAT THE LOOSENING MAY BE DUE TO A METAL ALLERGY. PAT ASYMMETRIC MODEL 184793, BEARING TIB MODEL 183666. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142760 FMRL PS OPEN INTL LT PROSTHESIS, KNEE, PATELOFEMORAL, SEMI-CONSTRAINED CEMENTED, POLYMER/METAL/POLYME JWH BIOMET INC. 141235 70MM-LOG831102

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention