BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET FINNED PRI STEM 40MM

    MDR report key: 2863982 · Received December 10, 2012

    Report

    Report Number
    0001825034-2012-02562
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    November 12, 2012
    Report Date
    November 20, 2012
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK043340
    Removal / Correction Number
    N/A
    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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 2 STATES, "EARLY OR LATE POSTOPERATIVE INFECTION AND/OR ALLERGIC REACTION." AND NUMBER 15 STATES, "INTEROPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED IN ACCORDANCE WITH ISO 11137-2. THIS REPORT IS NUMBER 2 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-02561 / 02563).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2011. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2012 DUE TO PAIN AND POSSIBLE INFECTION. THE STEM, TIBIAL TRAY AND BEARING WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET FINNED PRI STEM 40MM PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 043340

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R