BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BMT SPLINED KNEE STM 14X80

    MDR report key: 3905519 · Received July 1, 2014

    Report

    Report Number
    0001825034-2014-05883
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    July 27, 2011
    Report Date
    June 6, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK915132
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 2 STATES, "EARLY OR LATE POSTOPERATIVE INFECTION AND ALLERGIC REACTION." THIS REPORT IS NUMBER 5 OF 6 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2014-05879 / 05884).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2010 DUE TO INFECTION. ALL COMPONENTS WERE REMOVED AND REPLACED WITH CEMENT SPACERS. PATIENT UNDERWENT REIMPLANTATION ON (B)(6) 2010. IT WAS FURTHER REPORTED PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2011 DUE TO INFECTION. ALL COMPONENTS WERE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384313 BMT SPLINED KNEE STM 14X80 PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 564000

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R