BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIM INTERLOK PS FEMORAL 75 LEFT

    MDR report key: 3013249 · Received March 20, 2013

    Report

    Report Number
    0001825034-2013-00666
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 25, 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
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER WARNINGS IT STATES, "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. MALALIGNMENT OF THE COMPONENTS OR INACCURATE IMPLANTATION CAN LEAD TO EXCESSIVE WEAR AND/OR FAILURE OF THE IMPLANT OR PROCEDURE." THIS REPORT IS NUMBER 1 OF 5 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-00666 / 00670).

    Description of Event or Problem · 1

    A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY ON (B)(6) 2001. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO THE MALROTATION OF THE FEMORAL COMPONENT ON (B)(6) 2003. THE BEARING AND LOCKING BAR WERE REVISED ON (B)(6) 2006 FOR AN UNKNOWN REASON. IN ADDITION, THE PATIENT HAD A THIRD REVISION ON (B)(6) 2013 DUE TO LOOSENING OF THE FEMORAL AND TIBIAL COMPONENT. THE FEMORAL AND TIBIA COMPONENTS WERE REMOVED AND REPLACED WITH COMPETITOR'S PRODUCT. IT IS UNKNOWN IF THE PATELLA COMPONENT WAS LOOSE OR REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116622 MAXIM INTERLOK PS FEMORAL 75 LEFT PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 511650

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R