BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPICCI II KNEE FEMORAL COMPONENT 48MM LEFT MEDIAL

    MDR report key: 2071137 · Received April 27, 2011

    Report

    Report Number
    1825034-2011-00304
    Event Type
    Injury
    Date Received
    April 27, 2011
    Date of Event
    March 30, 2011
    Report Date
    March 31, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HRY
    PMA / PMN Number
    K971938
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. 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 APRIL 27, 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT PARTIAL KNEE ARTHROPLASTY ON (B)(6) 1998. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2011 TO REMOVE AND REPLACE COMPONENTS TO A TOTAL KNEE DUE TO DISEASE PROGRESSION. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPICCI II KNEE FEMORAL COMPONENT 48MM LEFT MEDIAL PROSTHESIS, KNEE HRY BIOMET ORTHOPEDICS N/A 845690

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R