BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK ASY,PS CEMENTED FEMORAL, SZ 4,

    MDR report key: 12045831 · Received June 22, 2021

    Report

    Report Number
    1038671-2021-00302
    Event Type
    Injury
    Date Received
    June 22, 2021
    Date of Event
    May 25, 2021
    Report Date
    December 29, 2021
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862063205
    PMA / PMN Number
    K032606
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REVISION REPORTED WAS MOST LIKELY THE RESULT OF ASEPTIC LOOSENING OF THE FEMORAL COMPONENT WITH POSSIBLE MECHANICAL CONTRIBUTIONS TO THE LOOSENING FROM INSTABILITY AND PATELLA BAJA. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION. THE MOST PROBABLE ROOT CAUSE ASSOCIATED WITH THE REPORTED EVENT OF "LOOSENING - FEMORAL" IS ASSOCIATED WITH WEAKENED INTEGRATION OF THE DEVICE AT THE BONE-IMPLANT INTERFACE DUE TO LOSS OF FIBROUS AND/OR BONY TISSUE AND LEADING TO COMPROMISED ANCHORAGE OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: THREE PEG PATELLA 35MM (CAT# 200-02-35 / SERIAL# (B)(4)), TRAPEZOID TIBIAL TRAY SZ 4F/5T (CAT# 204-04-45 / SERIAL# (B)(4)), TIBIAL INSERTS SZ 4, 9MM (CAT# 204-24-09 / SERIAL# (B)(4)). ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    AS REPORTED, THIS (B)(6) Y/O FEMALE PATIENT WAS REVISED DUE TO FEMUR LOOSENING. PATELLA EXCHANGE DUE TO "PATELLA BAJA". THERE IS NO HISTORICAL DATE REGARDING THE INITIAL IMPLANT AVAILABLE. THE FEMUR WAS LOOSE AND REPLACED BY A CC LOGIC OFFSET COUPLER AND A 18X120MM STEM, WITH A PSC INSERT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO IMPLANTS WERE DISPOSED BY HOSPITAL. ADDITIONAL INFORMATION RECEIVED INDICATES THAT BOTTOM RIGHT CORNER, THE METAL THAT HAS EMBEDDED INTO THE POLY FROM THE CLASSIC TIBIAL TRAY WHERE THE CAPS FOR THE AUGMENTS SIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    941942 OPTETRAK ASY,PS CEMENTED FEMORAL, SZ 4, PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. OPTETRAK ASY,PS CEMENTED FEMORAL, SZ 4, UNK 10885862063205

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Disability| R