BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PS TIBIAL INSERTS SZ 3, 9MM

    MDR report key: 15380864 · Received September 8, 2022

    Report

    Report Number
    1038671-2022-01057
    Event Type
    Injury
    Date Received
    September 8, 2022
    Date of Event
    April 4, 2016
    Report Date
    April 14, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862048301
    PMA / PMN Number
    K933610
    Removal / Correction Number
    Z-0019-2022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN ISSUES. THE CAUSE OF THE SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED, INSUFFICIENT INFORMATION.

    Additional Manufacturer Narrative · 0

    PENDING EVALUATION. CONCOMITANT MEDICAL PRODUCTS: 200-02-32 - THREE PEG PATELLA 32MM SN: (B)(4), 204-01-03 - PS CEMENTED FEMORAL SZ 3 SN: (B)(4), 204-04-33 - TRAPEZOID TIBIAL TRAY SZ 3F/3T SN: (B)(4), 203-96-01 - (11-2222) SAW BLADE NEW STRYK (.050) SN: (B)(4), 203-96-02 - (11-2324) SAW BLADE NEW STRYK (.035) SN: (B)(4), 203-96-03 - (11-2216) SAW BLADE NEW STRYKER (.050) SN: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS MALE PATIENT'S LEFT KNEE WAS REVISED 3 YEARS POST OP INITIAL TKA. REASON FOR THE REVISION WAS NOT REPORTED. NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325844 PS TIBIAL INSERTS SZ 3, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 204-23-09 UNK 10885862048301

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention