BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT

    MDR report key: 18981840 · Received March 26, 2024

    Report

    Report Number
    1038671-2024-00669
    Event Type
    Injury
    Date Received
    March 26, 2024
    Date of Event
    March 1, 2024
    Report Date
    April 4, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862174482
    PMA / PMN Number
    K111400
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11. CORRECTION - THIS CASE HAS BEEN DETERMINED TO BE A DUPLICATE. THIS CASE WILL BE CLOSED, ALL NEW/ADDITIONAL INFORMATION WILL BE REPORTED IN MFR#1038671-2024-00738.

    Additional Manufacturer Narrative · 0

    H10. D10. CONCOMITANTS: 5534094 200-02-35 THREE PEG PATELLA 35MM. 5054064 02-010-04-0340 LOGIC CR FEMORAL POR, RIGHT, SZ 4. 4410922 02-012-45-4040 LGC TIBIAL FIT TRAY CEM SZ 4F / 4T. H6. INVESTIGATION RESULTS -THE LOGIC CR TIB INSERT WITH SERIAL NUMBER (B)(6) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. THE CAUSE OF THE PATIENT¿S PAIN AND SWELLING CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION AS ASSOCIATED WITH THE INTERACTION BETWEEN THE IMPLANTED DEVICE AND THE PATIENT DUE TO PATIENT ILLNESS, UNIQUE ANATOMY, OR OTHER CONDITION THAT IMPACTS THE PERFORMANCE OF THE DEVICE. THE PATIENT HAS BILATERAL KNEE REPLACEMENTS. THE DEVICE HAS NOT BEEN EXPLANTED. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTS THAT A PATIENT IS HAVING RIGHT KNEE PAIN AND SWELLING. THE PATIENT HAD BILATERAL KNEE REPLACEMENTS ON (B)(6) 2018 AND WAS SCHEDULED FOR SURGICAL REVISION IN (B)(6) 2024. AS OF (B)(6) 2024, THERE HAS BEEN NO NOTIFICATION OF SURGICAL REVISION. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE ARE NO IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1333 LOGIC CR TIB INSERT PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862174482

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention