BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA PS MOD INSRT SZ 5 9MM

    MDR report key: 18550914 · Received January 22, 2024

    Report

    Report Number
    1038671-2024-00115
    Event Type
    Injury
    Date Received
    January 22, 2024
    Date of Event
    June 26, 2023
    Report Date
    December 6, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001924
    PMA / PMN Number
    K033883
    Removal / Correction Number
    Z-0584-2024
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: 2971710 02-010-01-0350 - LOGIC FEMORAL PS CEM RIGHT SZ 5 2992863 02-012-45-5050 - LGC TIBIAL FIT TRAY CEM SZ 5F / 5T 2990771 200-02-38 - THREE PEG PATELLA 38MM 10034014033 (B)(6)- GPS KNEE IMPLANT KIT PENDING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    RECALL NUMBER: Z-0021-2022. 1038671-2024-04662 THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 1038671-2024-04662 THE PRODUCT ASSOCIATED WITH THE REPORTED EVENT IS WITHIN THE SCOPE OF RECALL Z-0021-2022; HOWEVER, THERE IS INSUFFICIENT INFORMATION TO EVALUATE WHETHER THE SUBJECT ISSUE OF THE RECALL WAS A CAUSE OR CONTRIBUTOR TO THE REPORTED EVENT. D10: CONCOMITANTS: (B)(6), 02-010-01-0350 - LOGIC FEMORAL PS CEM RIGHT SZ 5, (B)(6), 02-012-45-5050 - LGC TIBIAL FIT TRAY CEM SZ 5F / 5T, (B)(6), 200-02-38 - THREE PEG PATELLA 38MM, (B)(6), A10007 - GPS KNEE IMPLANT KIT. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR AND FEMORAL 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

    AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6)2015. APPROXIMATELY 8 YEARS AND 2 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2023. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE. REVISION OP REPORT ON (B)(6) 2023 DIAGNOSIS: POLYETHYLENE WEAR AND OSTEOLYSIS WITH FEMORAL LOOSENING. THE PATIENT WAS NOTED TO HAVE A SIGNIFICANT EFFUSION. THERE WAS SIGNIFICANT POLY WEAR SYNOVITIS WITH GREY PEDUNCULATED TISSUE THROUGHOUT ALL THE COMPARTMENTS. THIS WAS CAREFULLY REMOVED. THE POLYETHYLENE INSERT WAS REMOVED WHICH WAS NOTED TO HAVE SOME WEAR, BUT NOT A LOT OF VOLUMETRIC WEAR. THE FEMORAL COMPONENT WAS NOTED TO HAVE SIGNIFICANT OSTEOLYSIS AND WAS EASILY REMOVED BY HAND. OSTEOLYSIS AND SCALLOPING FIBROUS TISSUE WAS PRESENT THROUGHOUT WAS ALL REMOVED. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN SATISFACTORY CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2052548 LOGIC TIBIA PS MOD INSRT SZ 5 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK 10885862001924

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Unknown Required Intervention| H SEE H10.| SEE H11.