BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAX PRI DCM TIBIAL BEARING12X79/83MM

    MDR report key: 3800142 · Received May 8, 2014

    Report

    Report Number
    0001825034-2014-03731
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    March 16, 2014
    Report Date
    May 29, 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
    TX, 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. EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA. 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."

    Additional Manufacturer Narrative · 1

    EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE. DURING THE EVALUATION, IT WAS DETERMINED THE WEAR ON THE BEARING WAS CONSIDERED NORMAL AND IN ACCORDANCE DESIGN FUNCTIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2001. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2014 DUE TO POLYETHYLENE WEAR. THE BEARING WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278827 MAX PRI DCM TIBIAL BEARING12X79/83MM PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 356540

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R