BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PS TIBIAL INSERTS SZ 2, 13MM

    MDR report key: 19121944 · Received April 16, 2024

    Report

    Report Number
    1038671-2024-00868
    Event Type
    Injury
    Date Received
    April 16, 2024
    Date of Event
    March 14, 2024
    Report Date
    December 16, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862048240
    PMA / PMN Number
    K933610
    Removal / Correction Number
    Z-0019-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) PENDING EVALUATION (D10) CONCOMITANT DEVICE(S): 2945216 204-36-12 - STEM EXTENSION W/SLOT 120L X16 MM. 3690120 208-01-02 - CC FEMORAL SZ 2. 2908401 208-07-02 - CC POSTERIOR FEM AUGMENT SZ 2, 5MM. 2905716 208-09-05 - CC STEM EXT ADAPTOR 5 DEGREE.

    Additional Manufacturer Narrative · 0

    THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR AND/OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES, RADIOGRAPHS, AND RELEVANT CLINICAL INFORMATION WERE NOT PROVIDED. H6: CORRECTED HEALTH EFFECT, COMPONENT, AND INVESTIGATION CLINICAL CODES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 64 YO FEMALE PATIENT, INITIAL RIGHT KNEE IMPLANTED ON (B)(6) 2015, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024, APPROXIMATELY 9 YEARS 2 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT¿S OPTETRAK CLASSIC PS POLY ON AN OPTETRAK CC FEMORAL COMPONENT WERE BEING REVISED FOR PAIN AND WEAR. DURING THE SURGERY, ONLY A TRULIANT ACTIVIT-E PS & PSC POLY WERE AVAILABLE, SO THE SURGEON IMPLANTED A TRULIANT PSC ACTIVIT-E POLY BUT KEPT THE OPTETRAK CC FEMUR IN PLACE. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. NO X-RAYS WERE ABLE TO BE OBTAINED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN AS THEY WERE DISPOSED OF. NO DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1340174 PS TIBIAL INSERTS SZ 2, 13MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK 10885862048240

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female SEE H10