BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PS TIBIAL INSERTS SZ 5, 9MM

    MDR report key: 19177870 · Received April 24, 2024

    Report

    Report Number
    1038671-2024-00970
    Event Type
    Injury
    Date Received
    April 24, 2024
    Date of Event
    April 8, 2024
    Report Date
    August 1, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862048462
    PMA / PMN Number
    K933610
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) PENDING EVALUATION: (D10) CONCOMITANT DEVICE(S): 1193360 - 200-02-38 - THREE PEG PATELLA 38MM. 1339036 - 200-04-55 - CEMENTED FINNED TIB. TRA SZ 5F/5T. 1359674 - 201-46-10 - HOLDING PIN HEADLESS 3" (4 PK). 82145 - 203-96-01 - (11-2222) SAW BLADE NEW STRYK (.050). 1317735 - 234-02-05 - OPTETRAK ASY,PS CEMENTED FEMORAL, SZ 5.

    Additional Manufacturer Narrative · 0

    D4: CORRECTED. H4: CORRECTED. H6: CORRECTED HEALTH EFFECT, MEDICAL DEVICE, COMPONENT, AND INVESTIGATION CLINICAL CODES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS PATIENT WAS REVISED APPROXIMATELY 16 YEARS POST OP DUE TO PAIN AND SOME INSTABILITY. NO ISSUES WITH SURGERY A PSC WAS FOUND TO BE MORE STABLE AT SAME THICKNESS. EXPLANTS NOT AVAILABLE. SURGEON STATED THE ORIGINAL INSERT PERFORMED WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1468984 PS TIBIAL INSERTS SZ 5, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK 10885862048462

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention