BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK TIBIAL INSERT

    MDR report key: 19114979 · Received April 16, 2024

    Report

    Report Number
    1038671-2024-00863
    Event Type
    Injury
    Date Received
    April 16, 2024
    Date of Event
    May 10, 2022
    Report Date
    October 11, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    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, INSTABILITY, INFECTION, OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. HOWEVER, THE REPORTED PROSTHESIS WEAR, AND INSTABILITY COULD NOT BE CONFIRMED AND POTENTIAL CONTRIBUTIONS OF MANUFACTURING, USER, OR PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND NO PRODUCT INFORMATION, IMAGES, RADIOGRAPHS, OR RELEVANT CLINICAL INFORMATION WAS PROVIDED. H6: CORRECTED HEALTH EFFECT, MEDICAL DEVICE, COMPONENT, AND INVESTIGATION CLINICAL CODES.

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION.

    Description of Event or Problem · 0

    LEGAL CASE ¿ USA (MDL NO. 3044) (NGG) (MMH) PATIENT ID: (B)(6). IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2019, AND THEN EXPERIENCED REVISION SURGICAL PROCEDURE ON (B)(6) 2022 APPROXIMATELY 3 YEARS AND 1 MONTH AFTER INITIAL IMPLANT. NO IMAGES WERE PROVIDED. THERE IS NO DEVICE INFORMATION PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582398 OPTETRAK TIBIAL INSERT PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention