BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CR TIBIAL INSERT SZ 3, 11MM, SLOPE +

    MDR report key: 16608683 · Received March 24, 2023

    Report

    Report Number
    1038671-2023-00503
    Event Type
    Injury
    Date Received
    March 24, 2023
    Date of Event
    May 16, 2017
    Report Date
    February 13, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862041074
    PMA / PMN Number
    K932690
    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

    PROCODE: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER. CONCOMITANT MEDICAL PRODUCTS: 2386961, 200-02-35 - THREE PEG PATELLA 35MM; 2232770, 204-04-32 - TRAPEZOID TIBIAL TRAY SZ 3F/2T; 2232807, 230-02-03 - OPTETRAK ASY,CR CEMENTED FEMORAL, SZ 3.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: G3/G4, H6. THE FOLLOWING SECTIONS WERE CORRECTED: H6 . MDR SECTION CODES UPDATED/CORRECTED: B, C, D, E, G. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR, FEMORAL LOOSENING, AND TIBIAL 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 AND RADIOGRAPHS WERE NOT PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED FROM THE LEGAL DEPARTMENT THAT ON (B)(6) 2012, THE PATIENT UNDERWENT A LEFT TOTAL KNEE REPLACEMENT WITH AN EXACTECH KNEE DEVICE. ON (B)(6) 2017, THE PATIENT UNDERWENT REVISION OF THE LEFT EXACTECH KNEE DEVICE SECONDARY TO CATASTROPHIC POLYETHYLENE LINER WEAR AND FAILURE WITH RESULTING METALLOSIS, OSTEOLYSIS, AND SYNOVITIS; APPROXIMATELY 4 YEARS, 9 MONTHS AFTER IMPLANT. IT IS ALSO STATED THAT DESPITE UNDERGOING THE REVISION SURGERY, 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
    583160 CR TIBIAL INSERT SZ 3, 11MM, SLOPE + SEE H10 JWH EXACTECH, INC. 200-63-11 10885862041074

    Patients

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