BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAX CR-LIP DCM BRNG 12X71/75

    MDR report key: 3121797 · Received May 21, 2013

    Report

    Report Number
    0001825034-2013-01592
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    April 22, 2013
    Report Date
    April 23, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK915132
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 11 STATES, "WEAR AND/OR DEFORMATION OF ARTICULATING SURFACES."

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY ON (B)(6) 2007. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2013 DUE TO WEAR AND INSTABILITY. THE TIBIAL BEARING WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224506 MAX CR-LIP DCM BRNG 12X71/75 PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 473440

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R