BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAX ILK ANA OPEN PS FMRL 65 RT

    MDR report key: 4869394 · Received June 25, 2015

    Report

    Report Number
    0001825034-2015-02737
    Event Type
    Injury
    Date Received
    June 25, 2015
    Date of Event
    June 9, 2015
    Report Date
    June 11, 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
    WA, 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: "PATELLAR TENDON RUPTURE AND LIGAMENTOUS LAXITY." THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2015-02736 & 02737).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2004. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2009 TO REPLACE THE TIBIAL BEARING FOR AN UNKNOWN REASON. ANOTHER REVISION PROCEDURE TOOK PLACE ON (B)(6) 2015 DUE TO FAILED EXTENSOR TENDON MECHANISM. ALL COMPONENTS WERE REPLACED AND A PATELLA TENDON ALLOGRAFT WAS AFFIXED TO THE QUAD TENDON AND TIBIAL TUBERCLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411275 MAX ILK ANA OPEN PS FMRL 65 RT PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 177990

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R