BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAX PRI DCM TIB BEARING18X71/75MM

    MDR report key: 3843476 · Received June 2, 2014

    Report

    Report Number
    0001825034-2014-05111
    Event Type
    Injury
    Date Received
    June 2, 2014
    Date of Event
    October 2, 2012
    Report Date
    May 7, 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
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 14 STATES, "PATELLAR TENDON RUPTURE AND LIGAMENTOUS LAXITY." THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-05110 / 05111).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT AN INITIAL LEFT KNEE PROCEDURE ON AN UNKNOWN DATE. SUBSEQUENTLY, PATIENT UNDERWENT REVISION PROCEDURES ON (B)(6) 2003, (B)(6) 2011, AND (B)(6) 2012. PATIENT'S PATELLA TENDON IS LAX AND DISLOCATES DUE TO PATIENT'S ANATOMY. TIBIAL BEARING WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321937 MAX PRI DCM TIB BEARING18X71/75MM PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 923280

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R