BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAX ILK ANA CON FEMORAL 60R RFVII

    MDR report key: 4633045 · Received March 25, 2015

    Report

    Report Number
    0001825034-2015-01165
    Event Type
    Injury
    Date Received
    March 25, 2015
    Date of Event
    March 9, 2015
    Report Date
    March 3, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK915132
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, 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: "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN"

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL RIGHT KNEE PROCEDURE ON (B)(6) 2001. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2015 DUE TO FEMORAL PAIN. THE FEMORAL COMPONENT WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200883 MAX ILK ANA CON FEMORAL 60R RFVII PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 677550

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R