BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAX PRI DCM TIB BRNG12X71/75MM

    MDR report key: 2992029 · Received March 7, 2013

    Report

    Report Number
    0001825034-2013-00505
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    February 20, 2013
    Report Date
    February 14, 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
    NC, 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 WARNINGS IT LISTS, "IMPROPER SELECTION, PLACEMENT, POSITIONING, ALIGNMENT AND FIXATION OF THE IMPLANT COMPONENTS MAY RESULT IN UNUSUAL STRESS CONDITIONS WHICH MAY LEAD TO SUBSEQUENT REDUCTION IN THE SERVICE LIFE OF THE PROSTHETIC COMPONENTS." THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-00504 / 00505).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT BILATERAL MAXIM TOTAL KNEE ARTHROPLASTY ON (B)(6) 2001. A SUBSEQUENT REVISION WAS PERFORMED ON (B)(6) 2013 DUE TO INSTABILITY. THE TIBIAL BEARING WAS REMOVED AND REPLACED. IT IS UNKNOWN WHICH SIDE WAS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97832 MAX PRI DCM TIB BRNG12X71/75MM PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 278250

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R