BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBALT HV BONE CEMENT 40MG

    MDR report key: 1462444 · Received September 3, 2009

    Report

    Report Number
    1825034-2009-00193
    Event Type
    Injury
    Date Received
    September 3, 2009
    Date of Event
    July 29, 2009
    Report Date
    July 30, 2009
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LOD
    PMA / PMN Number
    K051496
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. THIS REPORT FILED SEPTEMBER 3, 2009.

    Additional Manufacturer Narrative · 1

    THIS REPORT FILED SEPTEMBER 3, 2009.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT PARTIAL KNEE ARTHROPLASTY IN 2008. SUBSEQUENTLY, PATIENT WAS REVISED IN 2009, DUE TO FEMORAL LOOSENING. THE FEMORAL COMPONENT WAS REMOVED AND REPLACED. PRODUCT IDENTIFICATION WAS NOT PROVIDED UNTIL 2009.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT PARTIAL KNEE ARTHROPLASTY IN 2008. SUBSEQUENTLY, PATIENT WAS REVISED IN 2009 DUE TO FEMORAL LOOSENING. THE FEMORAL COMPONENT WAS REMOVED AND REPLACED. PRODUCT IDENTIFICATION WAS NOT PROVIDED UNTIL ABOUT TWO WEEKS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBALT HV BONE CEMENT 40MG BONE CEMENT LOD BIOMET ORTHOPEDICS N/A 554760

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R