BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBALT BONE CEMENT

    MDR report key: 1964354 · Received January 19, 2011

    Report

    Report Number
    1825034-2011-00045
    Event Type
    Injury
    Date Received
    January 19, 2011
    Report Date
    December 21, 2010
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LOD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LIMITED INFORMATION WAS PROVIDED RELATING TO THE EVENTS. FOLLOW UP ATTEMPTS TO OBTAIN FURTHER EVENT DETAILS AND PRODUCT WERE UNSUCCESSFUL. IN THE EVENT THAT BIOMET RECEIVES ADDITIONAL INFORMATION RELATING TO ANY OR ALL OF THE REPORTED EVENTS, A FOLLOW UP REPORT WILL BE SENT TO THE FDA. THE FOLLOWING INFORMATION COULD NOT BE PROVIDED SINCE NO PRODUCT IDENTIFICATION WAS RECEIVED: EXPIRY DATE; MANUFACTURE DATE. (B)(4).

    Description of Event or Problem · 1

    BIOMET RECEIVED A REPORT OF FOUR REVISION SURGERIES FOR FOUR DIFFERENT PATIENTS THAT WERE PERFORMED DUE TO THE COBALT CEMENT NOT BONDING TO THE IMPLANTS. THE DATES OF THE REVISION PROCEDURES AND PATIENT INFORMATION IS UNKNOWN. ONE OF THE REVISION SURGERIES INVOLVED A COMPETITOR'S FEMORAL COMPONENT THAT THE CEMENT DID NOT BOND TO. THE OTHER REVISION PROCEDURES INVOLVED BIOMET TIBIAL COMPONENTS WHERE THE CEMENT HAD NOT BONDED. THERE WAS NO PRODUCT IDENTIFICATION PROVIDED AND NO SURGEON OR PATIENT INFORMATION WAS GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBALT BONE CEMENT BONE CEMENT LOD BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R