BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA IMPLANT PSC INSERT, SZ 3, 11MM

    MDR report key: 16770108 · Received April 19, 2023

    Report

    Report Number
    1038671-2023-00750
    Event Type
    Injury
    Date Received
    April 19, 2023
    Date of Event
    August 1, 2022
    Report Date
    December 2, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862173560
    PMA / PMN Number
    K110547
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: CONCOMITANTS: 5013400 02-010-01-0330 - LOGIC FEMORAL PS CEM RIGHT SZ 3 4631886 02-012-45-3030 - LGC TIBIAL FIT TRAY CEM SZ 3F / 3T 4802151 200-02-38 - THREE PEG PATELLA 38MM.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR AND/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

    PER A REPORT FROM THE LEGAL DEPARTMENT, A 81 Y/O MALE PATIENT HAD AN INITIAL RIGHT KNEE REPLACEMENT ON (B)(6) 2017. APPROXIMATELY 4 YEARS AND 10 MONTHS AFTER INITIAL, THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2022. OP REPORT FAILED RIGHT KNEE REPLACEMENT DUE TO POLYETHYLENE WEAR AND SYNOVITIS. THE PATIENT BEGAN TO DEVELOP SOME SWELLING AND DISCOMFORT IN THE KNEE OVER THE PAST YEAR OF THE INITIAL PROCEDURE. THERE WAS MODERATE CHRONIC SYNOVITIS NOTED AND SYNOVECTOMY WAS PERFORMED INVOLVING THE SUPRAPATELLAR POUCH MEDIALLY AND LATERALLY. THE PLASTIC LINER WAS EASILY REMOVED. THERE WAS A FAIR AMOUNT OF WEAR NOTED ABOUT THE POST, BUT MEDIALLY AND LATERALLY AS WELL AS ABOUT THE UNDERSURFACE, IT APPEARED RELATIVELY WELL PRESERVED. THERE WERE NO COMPLICATIONS DURING THE REVISION PROCEDURE. THE PATIENT WAS AWOKEN AND REMOVED FROM THE OR TO THE RECOVERY ROOM IN STABLE CONDITION. 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
    1936337 LOGIC TIBIA IMPLANT PSC INSERT, SZ 3, 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER JWH EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 3, 11MM UNK 10885862173560

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Required Intervention