BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD UNI KNEE

    MDR report key: 9491136 · Received December 17, 2019

    Report

    Report Number
    MW5091739
    Event Type
    Injury
    Date Received
    December 17, 2019
    Date of Event
    March 12, 2019
    Report Date
    December 14, 2019
    Manufacturer
    ZIMMER BIOMET CANADA DFE
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    OXFORD PARTIAL KNEE DISLOCATED AND A PIECE OF CEMENT CAUSED A GROOVE IN GOOD SIDE OF KNEE. HAD A TOTAL KNEE REPLACEMENT AS A RESULT, 2 YRS TO THE MONTH AFTER PARTIAL. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1278808 OXFORD UNI KNEE PROSTHESIS, KNEE, FEMOROTIBIAL UNICOMPARTMENTAL, SEMI-CONSTRAINED METAL/POLYMER, JWH ZIMMER BIOMET CANADA DFE
    1278809 BONE CEMENT BONE CEMENT LOD UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| O| S