BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAX PRI DCM TIB BRNG10X71/75MM

    MDR report key: 5941136 · Received September 9, 2016

    Report

    Report Number
    0001825034-2016-03563
    Event Type
    Injury
    Date Received
    September 9, 2016
    Date of Event
    August 9, 2016
    Report Date
    January 13, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK915132
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 THE 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 11 STATES, ¿WEAR AND/OR DEFORMATION OF ARTICULATING SURFACES.¿ THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2016-03561 / 1825034-2016-03563). PRODUCT LOCATION UNKNOWN.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. CONCOMITANT PRODUCTS: PALACOS BONE CEMENT - CATALOGUE 424810 LOT 003647,BIOMET TIBIAL TRA- CATALOGUE 141233 LOT 727950,MAXIM FML - CATALOGUE 140072 LOT 605860.

    Description of Event or Problem · 1

    PATIENT UNDERWENT A LEFT KNEE REVISION PROCEDURE APPROXIMATELY 11 YEARS POST IMPLANTATION DUE TO A FRACTURED LOCKING BAR AND POLY WEAR. THE BEARING AND LOCKING BAR WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590032 MAX PRI DCM TIB BRNG10X71/75MM PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 750120

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R