BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PS TIBIAL INSERTS SZ 4, 9MM

    MDR report key: 19555013 · Received June 17, 2024

    Report

    Report Number
    1038671-2024-01944
    Event Type
    Injury
    Date Received
    June 17, 2024
    Date of Event
    May 21, 2024
    Report Date
    May 27, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862048387
    PMA / PMN Number
    K933610
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (H3) PENDING EVALUATION (D10) CONCOMITANT DEVICE(S): 1022203 - 200-02-38 - THREE PEG PATELLA 38MM 727408 - 204-04-45 - TRAPEZOID TIBIAL TRAY SZ 4F/5T 918521 - 204-32-01 - FLUTED STEM EXTENSION 11L X 12 MM 468732 - 204-45-05 - TIBIAL AUGMENT BLOCK 1/3-SZ 5 5MM 1036935 - 204-70-00 - TIBIAL STEM EXT. SCREW 1008148 - 234-02-04 - OPTETRAK ASY,PS CEMENTED FEMORAL, SZ 4,

    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: B, C, D, G. THE REASON FOR THE REPORTED REVISION DUE TO INFECTION CANNOT BE CONCLUSIVELY DETERMINED FROM THE INFORMATION PROVIDED, BUT MAY BE RELATED TO AN UNDERLYING PATIENT CONDITION. BASED ON THE LENGTH OF IMPLANTATION, THE INFECTION DOES NOT APPEAR RELATED TO THE DEVICE OR SURGICAL PROCEDURE, THEREFORE STERILE CERTIFICATION AND/OR FINAL ENDOTOXINS REPORTS WERE NOT REVIEWED. INFECTION IS A KNOWN RISK, 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

    IT WAS REPORTED THAT THIS 82 Y/O MALE PATIENT'S LEFT KNEE WAS REVISED APPROXIMATELY 17 YEARS POST OP. THE PATIENT WAS REVISED DUE TO INFECTION. PATIENT WAS REVISED TO SAME SIZE PS TIBIAL INSERT SZ 4 9MM. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED. PRODUCT NOT RETURNING - HOSPITAL POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1332431 PS TIBIAL INSERTS SZ 4, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK 10885862048387

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male Required Intervention SEE H11