BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIM ILOK ANA PRI FML 70 RT

    MDR report key: 6367626 · Received March 1, 2017

    Report

    Report Number
    0001825034-2017-01208
    Event Type
    Injury
    Date Received
    March 1, 2017
    Date of Event
    September 26, 2016
    Report Date
    March 1, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK915132
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 THE 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 6 STATES, "INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS." NUMBER 11 STATES, "WEAR AND/OR DEFORMATION OF ARTICULATING SURFACES." NUMBER 15 STATES, "INTEROPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." NUMBER 4 STATES, "LOOSENING OR MIGRATION OF THE IMPLANTS CAN OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION, EXCESSIVE ACTIVITY." CONCOMITANT MEDICAL PRODUCTS - LOCKING BAR - CATALOGUE: 141205, LOT: 785050. TIBIAL TRAY - CATALOGUE: 141224, LOT: 668040. BEARING - CATALOGUE: 11-146152, LOT: 268960. PATELLA - CATALOGUE: 11-150844, LOT: 786270. THIS REPORT IS NUMBER 1 OF 3 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2016-03466 / 03467 AND 0001825034-2017-01208 ).

    Description of Event or Problem · 1

    PATIENT UNDERWENT A RIGHT KNEE REVISION 14 YEARS POST-OP DUE TO PAIN, SWELLING, LACK OF RANGE OF MOTION, CLICKING SOUND, POLYETHYLENE WEAR, POSTERIOR CRUCIATE LIGAMENT LAXITY, AND LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151501 MAXIM ILOK ANA PRI FML 70 RT PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 831410

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention