BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK

    MDR report key: 9700049 · Received February 12, 2020

    Report

    Report Number
    1038671-2020-00072
    Event Type
    Injury
    Date Received
    February 12, 2020
    Date of Event
    January 17, 2020
    Report Date
    April 16, 2020
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862063199
    PMA / PMN Number
    K932776
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) THE EVALUATION NOTED THAT THE REASON FOR THE REVISION REPORTED WAS LIKELY THE RESULT OF AN INSUFFICIENT BOND BETWEEN THE IMPLANT AND THE BONE WHICH LED TO ASEPTIC (NON-INFECTED) LOOSENING OF THE TIBIAL TRAY. HOWEVER, THIS CANNOT BE CONFIRMED BECAUSE THE COMPONENT WAS NOT RETURNED FOR EVALUATION. (D11) CONCOMITANT DEVICES: TIBIAL INSERT (CAT# 204-23-09). TIBIAL TRAY (CAT# 200-04-32). NO INFORMATION PROVIDED IN THE FOLLOWING SECTION(S): B6, D4 (SERIAL NUMBER AND EXP NUMBER), H4.

    Additional Manufacturer Narrative · 0

    SECTION H11: (D2) COMMON DEVICE NAME. (D4) CATALOG NUMBER CHANGED TO 200-04-32, AND UDI NUMBER UPDATED. (D11) CONCOMITANT DEVICES UPDATED TO; TIBIAL INSERT (CAT# 204-23-09). FEMORAL (CAT# 234-02-03). (G5) 510K NUMBER UPDATED TO K932776.

    Additional Manufacturer Narrative · 1

    PENDING ENGINEERING EVALUATION OR ¿ENGINEERING EVALUATION SUMMARY¿. CONCOMITANT DEVICES: TIBIAL INSERT (CAT# 204-23-09); TIBIAL TRAY (CAT# 200-04-32).

    Description of Event or Problem · 1

    AS REPORTED BY THE EXACTECH KNEE REPLACEMENT STUDY, THE (B)(6) Y/O FEMALE PATIENT WAS INITIALLY IMPLANTED ON (B)(6) 2016. THE PATIENT EXPERIENCED AN LEFT ASEPTIC TIBIAL LOOSENING. PATIENT WEIGHS (B)(6) LBS. PATIENT WITH CLINICAL AND RADIOLOGICAL SIGNS COMPATIBLE WITH ASEPTIC LOOSENING OF THE TIBIAL COMPONENT, IS TAKEN TO REVIEW THE TIBIAL COMPONENT OF LEFT RTR, ON (B)(6) 2020, THE FEMORAL COMPONENT IS STABLE IS NOT REVIEWED, PROCEDURE WITHOUT COMPLICATIONS, DISCHARGED ON (B)(6) 2020. THE EVENT IS NOT RELATED TO THE DEVICE BUT POSSIBLY RELATED TO THE PROCEDURE. DEVICES NOT RETURNING. ALL AVAILABLE INFORMATION RECEIVED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166780 OPTETRAK CEMENTED FINNED TIB. TRA SZ 3F/2T JWH EXACTECH, INC. 234-02-03 UNK 10885862063199

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention