BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER BIOMET OXFORD KNEE

    MDR report key: 7150585 · Received December 27, 2017

    Report

    Report Number
    MW5074262
    Event Type
    Injury
    Date Received
    December 27, 2017
    Date of Event
    June 16, 2017
    Report Date
    December 23, 2017
    Manufacturer
    ZIMMER / BIOMET
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD A UNI COMPARTMENTAL KNEE REPLACEMENT IN (B)(6) 2016. A ZIMMER BIOMET OXFORD UNIT. IN (B)(6) 2017, THE FREE FLOATING MENISCAL BEARING EJECTED ITSELF COMPLETELY FROM IN BETWEEN THE FEMORAL COMPONENT AND TIBIAL COMPONENT LODGING ITSELF UP UNDER THE PATELLA. URGENT SURGERY TO REMOVE THAT AND REPLACE IT WITH A 2MM THICKER ONE. AGAIN, THAT SURGERY FAILED EXACTLY THE SAME IN (B)(6) 2017. AGAIN, URGENT SURGERY TO REPLACE WITH A FULL KNEE. THIS HAS RESULTED IN A LOT OF PAIN. I BELIEVE THIS PRODUCT IS DEFECTIVE DUE TO THE "FREE FLOATING MENISCAL BEARING," NOTHING HOLDING IT IN PLACE, A BAD DESIGN. PLEASE LOOK INTO THIS. TWO FAILED SURGERIES IN LESS THAN 6 MONTHS BETWEEN. I HAVE MEDICAL RECORDS AND SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    928860 ZIMMER BIOMET OXFORD KNEE PROSTHESIS, KNEE JWH ZIMMER / BIOMET

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R