BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODULAR TAPERLOC FEMORAL REDUCED DISTAL 20 X 160MM TYPE I TAPER

    MDR report key: 1913004 · Received December 2, 2010

    Report

    Report Number
    1825034-2010-00643
    Event Type
    Injury
    Date Received
    December 2, 2010
    Date of Event
    September 2, 2010
    Report Date
    November 8, 2010
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    K030055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    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. THIS REPORT FILED (B)(6) 2010.

    Description of Event or Problem · 1

    PATIENT REPORTED THAT HE UNDERWENT RIGHT HIP ARTHROPLASTY IN 2005 UTILIZING METAL-ON-METAL COMPONENTS AND HAS SUBSEQUENTLY BEEN REVISED DUE TO FAILURE OF THE IMPLANTS. REVIEW OF SALES AND INVOICE HISTORY REVEALED THAT THE ORIGINAL PROCEDURE TOOK PLACE ON (B)(6) 2005. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODULAR TAPERLOC FEMORAL REDUCED DISTAL 20 X 160MM TYPE I TAPER PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 122730

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R