BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAX PRI DCM TIB BRNG10X71/75MM

    MDR report key: 5574473 · Received April 13, 2016

    Report

    Report Number
    0001825034-2016-01267
    Event Type
    Injury
    Date Received
    April 13, 2016
    Date of Event
    March 8, 2016
    Report Date
    March 16, 2016
    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
    PATIENT

    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 9 STATES, "FATIGUE FRACTURE OF COMPONENT CAN OCCUR AS A RESULT OF LOSS OF FIXATION, STRENUOUS ACTIVITY, MALALIGNMENT, TRAUMA, NON-UNION, OR EXCESSIVE WEIGHT." NUMBER 11 STATES, ¿WEAR AND/OR DEFORMATION OF ARTICULATING SURFACES.¿ THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 3 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2016-01259 / 01265 / 01267 / 01268). PRODUCT LOCATION UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT PATIENT UNDERWENT RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2000. DURING THE PROCEDURE, PATIENT EXPERIENCED A DBT. SUBSEQUENTLY, PATIENT UNDERWENT LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2003. DURING THIS PROCEDURE, PATIENT EXPERIENCED A PULMONARY EMBOLISM. SUBSEQUENTLY, PATIENT UNDERWENT A RIGHT KNEE REVISION PROCEDURE ON (B)(6) 2016 DUE TO ALLEGATIONS OF ELEVATED METAL ION LEVELS AND POLY WEAR. IT WAS FURTHER REPORTED THAT THE TIBIAL BEARING WAS WORN, WHICH RESULTED IN THE BEARING BREAKING IN HALF. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229478 MAX PRI DCM TIB BRNG10X71/75MM PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 437470

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R