BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOMET ORTHOPEDICS

    MDR report key: 2306918 · Received October 19, 2011

    Report

    Report Number
    MW5022742
    Event Type
    Other
    Date Received
    October 19, 2011
    Date of Event
    January 26, 2010
    Report Date
    October 19, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MY NAME IS (B)(6) - IN (B)(6) 2010. I HAD A TOTAL KNEE REPLACEMENT THIS PRODUCT WAS APPROVED BY THE FDA - THIS PRODUCT FAILED - THEREFORE I HAD TO HAVE THE SAME KNEE REDONE. DR (B)(6) DID MY FIRST, BUT REFUSED TO LISTEN TO ME IN (B)(6) 2010, WHEN I HAD AN OFFICE VISIT TO TRY AND TELL HIM OF THE SEVERE PAIN IN MY RIGHT KNEE. SO, I STARTED CALLING AROUND FOR A SECOND OPINION, THIS IS WHEN DR STILL TOOK OVER IN (B)(6) 2011, I HAD A TOTAL REVISION REPLACEMENT. I CONSULTED A LAWYER, BUT BEING THIS PRODUCT WAS APPROVED BY THE FDA, THE LAWYER ASKED THAT I SEND THIS INFO TO YOU FOR YOUR RECORDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET ORTHOPEDICS VANGUARD DCM TIBIAL BEARING JWH BIOMET ORTHOPEDICS
    10 BIOMET ORTHOPEDICS COBALT G-HV BONE CEMENT - 40/20 LOD BIOMET ORTHOPEDICS
    2 BIOMET ORTHOPEDICS BIOMET PRIMARY TIBIAL PLATE HRS BIOMET ORTHOPEDICS
    3 BIOMET ORTHOPEDICS BIOMET MODULAR FINNED STEM LPH BIOMET ORTHOPEDICS
    4 BIOMET ORTHOPEDICS VANGUARD CR FEMORAL JWH BIOMET ORTHOPEDICS
    5 BIOMET ORTHOPEDICS BIOMET ARCOM ALL POLYPAT BUTTON JWH BIOMET ORTHOPEDICS
    6 BIOMET ORTHOPEDICS LOW PROFILE SELF-TAPPING HWC BIOMET ORTHOPEDICS
    7 BIOMET ORTHOPEDICS LOW PROFILE SELF-TAPPING HWC BIOMET ORTHOPEDICS
    8 BIOMET ORTHOPEDICS LOW PROFILE SELF-TAPPING HWC BIOMET ORTHOPEDICS
    9 BIOMET ORTHOPEDICS LOW PROFILE SELF-TAPPING HWC BIOMET ORTHOPEDICS

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR