BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PS TIBIAL INSERTS SZ 3, 18MM

    MDR report key: 16639996 · Received March 29, 2023

    Report

    Report Number
    1038671-2023-00543
    Event Type
    Injury
    Date Received
    March 29, 2023
    Date of Event
    February 7, 2019
    Report Date
    June 23, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862048349
    PMA / PMN Number
    K933610
    Removal / Correction Number
    Z-0019-2022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PROCODES: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER. CONCOMITANT MEDICAL PRODUCTS: 9000350 208-01-03 - CC FEMORAL SZ 3; 1228459 204-34-04 - FLUTED STEM EXTENSION 40L X 14 MM; 1323832 208-05-03 - CC DISTAL FEM AUGMENT SZ 3, 5MM; 1352399 208-05-03 - CC DISTAL FEM AUGMENT SZ 3, 5MM; 2142929 208-09-05 - CC STEM EXT ADAPTOR 5 DEGREE. PENDING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR, INFECTION, INSTABILITY, AND LOOSENING OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES, RADIOGRAPHS, AND RELEVANT CLINICAL INFORMATION WERE NOT PROVIDED. H6: CORRECTED HEALTH EFFECT, MEDICAL DEVICE, COMPONENT, AND INVESTIGATION CLINICAL CODES.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTS THAT ON (B)(6) 2019, THE FEMALE PATIENT UNDERWENT A SECOND REVISION OF THE RIGHT EXACTECH KNEE DEVICE SECONDARY TO POLYETHYLENE LINER WEAR, APPROXIMATELY 6 YEARS 2 MONTHS AFTER THE FIRST REVISION PROCEDURE. IT IS STATED THAT DESPITE UNDERGOING THE REVISION SURGERIES, THE PATIENT EXPERIENCES DAILY KNEE PAIN AND DISCOMFORT WHICH LIMIT ACTIVITIES OF DAILY LIVING AND RECREATION AND IMPACTS QUALITY OF LIFE. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571477 PS TIBIAL INSERTS SZ 3, 18MM SEE H10 JWH EXACTECH, INC. 204-23-18 10885862048349

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention SEE H10