BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PS TIBIAL INSERTS SZ 3, 13MM

    MDR report key: 16843377 · Received May 1, 2023

    Report

    Report Number
    1038671-2023-00867
    Event Type
    Injury
    Date Received
    May 1, 2023
    Date of Event
    March 15, 2023
    Report Date
    July 5, 2023
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862048325
    PMA / PMN Number
    K933610
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS WEAR OF THE TIBIAL INSERT AND PATELLA POSSIBLY DUE TO MALALIGNMENT BETWEEN THE IMPLANTS, HIGH CONTACT STRESSES DURING KNEE FLEXION/EXTENSION, THIRD BODY WEAR, PATIENT-RELATED CONDITIONS, INSTABILITY, OR ANY COMBINATION OF THESE POSSIBILITIES. THE CAUSE OF THE PROSTHESIS WEAR AND REPORTED LOOSENING CANNOT BE DETERMINED BECAUSE THE REVISED COMPONENTS WERE NOT RETURNED FOR EVALUATION AND NO RADIOGRAPHS WERE PROVIDED. AN ADDITIONAL CONTRIBUTING FACTOR TO THE REVISION MAY HAVE BEEN INCLUSION OF THE IMPLANTED TIBIAL INSERT IN THE PACKAGING RECALL.

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. H10: OPTETRAK 3 PEG PATELLA 29MM - 200-02-29 - 2161439; OPTETRAK TIBIAL TRAY, CEMENTED SZ 3F/3T - 204-04-33 - 2167036; OPTETRAK PS FEMORAL, CEMENTED SIZE 3 LEFT - 234-02-03 - 2150806. H7: Z-0019-2022.

    Description of Event or Problem · 0

    AS REPORTED, THE PATIENT HAD AN INITIAL LEFT TKA ON (B)(6) 2012. THE PATIENT HAD A POLY AND PATELLA REVISION ON (B)(6) 2023 DUE TO THE COMPONENTS BEING LOOSE AND WORN. PARTS AND PIECES FELL INTO THE PATIENT WOUND SITE AND WERE REMOVED BY THE SURGEON. FRAGMENTS OF POLYETHYLENE WERE PRESENT IN THE KNEE JOINT. THERE WAS A 5-15 MINUTE SURGICAL DELAY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENTS A RESULT OF THE DELAY. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1274939 PS TIBIAL INSERTS SZ 3, 13MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. 204-23-13 10885862048325

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Required Intervention SEE H10