BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PS TIBIAL INSERTS SZ 2, 9MM

    MDR report key: 21137666 · Received January 13, 2025

    Report

    Report Number
    1038671-2025-00202
    Event Type
    Injury
    Date Received
    January 13, 2025
    Date of Event
    March 29, 2019
    Report Date
    June 3, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862048226
    PMA / PMN Number
    K933610
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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 AND TIBIAL LOOSENING. 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 AND RADIOGRAPHS WERE NOT PROVIDED. H6: CORRECTED HEALTH EFFECT AND INVESTIGATION CLINICAL CODES.

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANT DEVICES: (B)(6) 234-02-02 - OPTETRAK ASY,PS CEMENTED FEMORAL, SZ 2, (B)(6) 200-04-22 - CEMENTED FINNED TIB. TRA SZ 2F/2T (B)(6) 200-02-29 - THREE PEG PATELLA 29MM THE PRODUCT ASSOCIATED WITH THE REPORTED EVENT IS WITHIN THE SCOPE OF RECALL Z-0019-2022; HOWEVER, THERE IS INSUFFICIENT INFORMATION TO EVALUATE WHETHER THE SUBJECT ISSUE OF THE RECALL WAS A CAUSE OR CONTRIBUTOR TO THE REPORTED EVENT. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 117 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR AND LOOSENING OF THE TIBIAL COMPONENT. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. POSTOPERATIVE DIAGNOSIS NOTED LOOSE LEFT KNEE TIBIAL COMPONENT. INTRAOPERATIVELY TWO WOUND CULTURES WERE SENT OFF WITH NO INFECTION APPRECIATED AND CULTURE RESULTS WERE UNREMARKABLE. IT WAS NOTED THAT THE SURGEON ELECTED DO THE TIBIAL REVISION AND NOT THE WHOLE KNEE. IT WAS NOTED THAT THE TIBIAL COMPONENT WAS SIGNIFICANTLY LOOSE. PATIENT WAS REVISED TO EXACTECH DEVICES. NO MEDICAL OR SURGICAL INTERVENTIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE THE SERIAL NUMBER (B)(6) IS CONFIRMED TO BE A PART OF RECALL NUMBER: Z-0019-2022 204-22-09 - PS TIBIAL INSERTS SZ 2, 9MM SERIAL: (B)(6)510K: K933610 UDI: (B)(4)' PRODUCT CODE: JWH X-RAY: NO OPERATIVE NOTES: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499583 PS TIBIAL INSERTS SZ 2, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862048226

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Hospitalization| R SEE H11