BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK

    MDR report key: 9368977 · Received November 25, 2019

    Report

    Report Number
    1038671-2019-00583
    Event Type
    Injury
    Date Received
    November 25, 2019
    Date of Event
    November 12, 2019
    Report Date
    May 14, 2020
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862039590
    PMA / PMN Number
    K932690
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) THE EVALUATION NOTED IN THE REVISION AS REPORTED, A 79 Y/O FEMALE PATIENT¿S RIGHT KNEE WAS INITIALLY IMPLANTED (B)(6) 2018. ON (B)(6) 2019, THE PATIENT WAS REVISED DUE TO THE PATELLA WAS MAL-TRACKING DUE TO 2 DEGREE TO VMO WEAKNESS. DEVICES WILL NOT BE RETURNED, PHOTOS RECEIVED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. ALL AVAILABLE INFORMATION HAS BEEN RECEIVED. UPON REVIEW OF THIS EVENT, THERE IS NO EVIDENCE THIS IS A DEVICE RELATED ISSUE. THE MOST LIKELY CAUSE WAS DUE TO THE 2 DEGREE TO VMO WEAKNESS, AS REPORTED; HOWEVER, THIS CANNOT BE CONFIRMED DUE TO THE DEVICES WERE NOT RETURNED. (D11) CONCOMITANT DEVICE(S): LGC TIBIAL FIT TRAY CEM SZ 2.5F / 5T (CAT# 02-012-45-2525 / SN# (B)(6). LGC FEMORAL PS CEM RIGHT SZ 2.5 (CAT# 02-010-01-0325 / SN# (B)(6). FLUTED STEM EXTENSION 25L X 14 MM (CAT# 204-34-02 / SN# (B)(6). LOGIC TIBIA IMPLANT PSC INSERT, SZ 2.5, 11MM (CAT# 02-012-44-2511 / SN# (B)(6). NO INFORMATION PROVIDED IN THE FOLLOWING SECTION(S): A4, A5, AND B6. THE FOLLOWING SECTION(S) HAVE ADDITIONAL INFO: B5, G4, G7, H1, H2, H3, H6 AND H7.

    Description of Event or Problem · 0

    AS REPORTED, A 79 Y/O FEMALE PATIENT¿S RIGHT KNEE WAS INITIALLY IMPLANTED (B)(6) 2018. ON (B)(6) 2019, THE PATIENT WAS REVISED DUE TO THE PATELLA WAS MAL-TRACKING DUE TO 2 DEGREE TO VMO WEAKNESS. DEVICES WILL NOT BE RETURNED, PHOTOS RECEIVED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. ALL AVAILABLE INFORMATION HAS BEEN RECEIVED.

    Additional Manufacturer Narrative · 1

    PENDING EVALUATION. CONCOMITANT DEVICE(S): LGC TIBIAL FIT TRAY CEM SZ 2.5F / 5T (CAT# 02-012-45-2525 / SN# (B)(4)), LGC FEMORAL PS CEM RIGHT SZ 2.5 (CAT# 02-010-01-0325 / SN# (B)(4)), FLUTED STEM EXTENSION 25L X 14 MM (CAT# 204-34-02 / SN# (B)(4)), LOGIC TIBIA IMPLANT PSC INSERT, SZ 2.5, 11MM (CAT# 02-012-44-2511 / SN# (B)(4)).

    Description of Event or Problem · 1

    THE PATELLA WAS MALTRACKING DUE TO 2 DEG TO VMO WEAKNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1163280 OPTETRAK THREE PEG PATELLA 32MM JWH EXACTECH, INC. 200-02-32 10885862039590

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention SEE H10.