BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBALT HV BONE CEMENT 40G

    MDR report key: 2444375 · Received February 9, 2012

    Report

    Report Number
    0001825034-2012-00110
    Event Type
    Injury
    Date Received
    February 9, 2012
    Date of Event
    May 2, 2012
    Report Date
    January 12, 2012
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LOD
    PMA / PMN Number
    PK051496
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LEGAL DEPARTMENT RECEIVED X-RAYS ON (B)(6), 2012. EVALUATION OF THE X-RAYS INDICATED THERE WAS NO EVIDENCE OF GROSS LOOSENING. WITHOUT FURTHER INFORMATION, NO DEFINITE CONCLUSION CAN BE MADE AS TO THE CAUSE OF THE COMPLAINT. (B)(4).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY THE REASON FOR AND DATE OF THE REVISION PROCEDURE. THIS FOLLOW-UP REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-00109-2).

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR. THE INSERT STATES: LOOSENING OR DISPLACEMENT OF THE PROSTHESIS THE USER FACILITY WAS NOTIFIED OF THE EVENT ON FEBRUARY 8, 2012. IN THE EVENT THAT THE USER FACILITY SUBMITS A MEDWATCH REPORT, BIOMET WILL FORWARD A COPY TO THE FDA. THIS IS MDR TWO OF TWO (1825034-2012-00109 AND 1825034-2012-00110) FOR THIS EVENT.

    Description of Event or Problem · 1

    PATIENT REPORTED UNDERGOING A KNEE ARTHROPLASTY IN (B)(6) 2010. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6), 2012, DUE TO LOOSENING. THE SURGEON NOTED THAT THE TIBIAL COMPONENTS DID NOT APPEAR TO BE FIXED AT THE CEMENT/IMPLANT INTERFACE.

    Description of Event or Problem · 1

    PATIENT REPORTED UNDERGOING A KNEE ARTHROPLASTY IN (B)(6) 2010. PATIENT REPORTS HE RETURNED TO HIS DOCTOR'S OFFICE COMPLAINING OF KNEE PAIN. UPON REVIEW OF IMAGING, THE PATIENT REPORTS HIS DOCTOR RECOMMENDS A REVISION DUE TO ALLEGED ADHESIVE FAILURE AND LOOSE TIBIAL TRAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBALT HV BONE CEMENT 40G COBALT HV BONE CEMENT 40G LOD BIOMET ORTHOPEDICS N/A 806570

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R