BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBALT G HV BONE CEMENT

    MDR report key: 1875198 · Received October 19, 2010

    Report

    Report Number
    1825034-2010-00445
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Report Date
    September 24, 2010
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LOD
    PMA / PMN Number
    K051532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPDATED TO CORRECT THE DATE OF THE INITIAL PROCEDURE TO (B)(6) 2010.(B)(4)..

    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: LOOSENING AND FRACTURE OF EITHER THE CEMENT OR THE PROSTHESIS, OR BOTH, CAN OCCUR DUE TO DISEASE, TRAUMA, AND INADEQUATE CEMENTING TECHNIQUE, MECHANICAL FAILURE OF THE MATERIALS OR LATENT INFECTION. THIS REPORT FILED (B)(6) 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2009. SUBSEQUENTLY, THE PATIENT BEGAN TO EXPERIENCE PAIN AND RADIOGRAPHS REVEALED TIBIAL TRAY LOOSENING. A REVISION PROCEDURE HAS NOT BEEN REPORTED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2009. SUBSEQUENTLY, THE PATIENT BEGAN TO EXPERIENCE PAIN AND RADIOGRAPHS REVEALED TIBIAL TRAY LOOSENING. A REVISION PROCEDURE HAS NOT BEEN REPORTED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBALT G HV BONE CEMENT BONE CEMENT LOD BIOMET ORTHOPEDICS N/A 570810

    Patients

    Seq Age Sex Outcome Treatment
    1