BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PS TIBIAL INSERTS SZ 2, 9MM

    MDR report key: 17297215 · Received July 11, 2023

    Report

    Report Number
    1038671-2023-01600
    Event Type
    Injury
    Date Received
    July 11, 2023
    Date of Event
    June 15, 2023
    Report Date
    July 31, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862048226
    PMA / PMN Number
    K933610
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) PENDING EVALUATION (D10) CONCOMITANT DEVICE(S): 200-02-32 - THREE PEG PATELLA 32MM 1416422 204-01-02 - PS CEMENTED FEMORAL SZ 2 8101073 204-04-23 - TRAPEZOID TIBIAL TRAY SZ 1F/3T, 2F/3T 1306396 204-32-01 - FLUTED STEM EXTENSION 11L X 12 MM 1180531 620-00-02 - PLATELET RICH PLASMA KIT WITH SPRAY TIPS 101311 620-11-02 - ACCELERATE CONC. SYS REP BY 620-12-02 6001290901.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: H6. MDR SECTION CODES UPDATED/CORRECTED: A, B, C, D, E, G. THE REASON FOR THE REPORTED REVISION DUE TO INSTABILITY CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT MAY BE DUE TO SOFT TISSUE IMBALANCE, PATIENT ANATOMY, IMPLANT POSITIONING, AND/OR IMPLANT SELECTION. INSTABILITY IS A KNOWN RISKS, AS OUTLINED IN THE IFU. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 14 YEARS POST OP INITIAL RIGHT TKA, THIS 83 Y/O FEMALE PATIENT WAS REVISED. KNEE WAS UNSTABLE, SURGEON DID A POLY EXCHANGE OF OLD OPTETRAK. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. UNKNOWN MEDICAL HISTORY. X-RAY WAS PROVIDED AS WELL AS A PICTURE OF HER OPERATIVE REPORT FROM 2009. PRODUCT NOT BEING RETURNED DUE TO THE ACCOUNT WOULD NOT RETURN THE PRODUCT DUE TO THEIR GUIDELINES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2193557 PS TIBIAL INSERTS SZ 2, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK UNK 10885862048226

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female SEE H10