BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC

    MDR report key: 18476365 · Received January 9, 2024

    Report

    Report Number
    1038671-2024-00047
    Event Type
    Injury
    Date Received
    January 9, 2024
    Date of Event
    November 28, 2023
    Report Date
    April 15, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862159212
    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

    D2B: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER D10: CONCOMITANTS: 5737675 - 02-010-04-0325 - LOGIC CR FEMORAL POR, RIGHT, SZ 2.5 5679574 - 2-012-45-2525 - LGC TIBIAL FIT TRAY CEM SZ 2.5F / 5T 5687943 - 200-02-35 - THREE PEG PATELLA 35MM 5967721 - 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK 5776339 - 201-78-81 - 3 TROCAR, MOD. HEX 2PK 5440259 - 521-78-23 - THREADED PIN SIZE 2.3 COLLARED S011724 - 521-78-23 - THREADED PIN SIZE 2.3 COLLARED S017711 - 521-78-32 - THREADED PIN SIZE 3.0 COLLARLESS 2029019123 ¿ (B)(6) - GPS IMPLANT KIT V2 6 ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS WEAR OF THE TIBIAL INSERT SECONDARY TO INSTABILITY AND PATIENT-RELATED ISSUES. INSTABILITY OF THE KNEE MAY HAVE ALLOWED FOR EXCESSIVE POSTERIOR AND MEDIAL CONTACT LEADING TO FULL-THICKNESS WEAR OF THE POLYETHYLENE TIBIAL INSERT. A CONTRIBUTING FACTOR TO THE WEAR ON THE TIBIAL INSERT MAY HAVE BEEN RESULT OF BEING PACKAGED IN A NON-CONFORMING VACUUM BAG FOR MORE THAN FIVE YEARS. THERE DOES NOT APPEAR TO BE A WEAR ISSUE WITH THE EXPLANTED PATELLA. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 56 YO FEMALE PATIENT, INITIAL RIGHT KNEE IMPLANTED ON (B)(6) 2019, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2023, APPROXIMATELY 4 YEARS 5 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT WAS REVISED DUE TO PATELLA WEAR AND THE DELAMINATION OF THE TIBIAL INSERT. THE LINER AND PATELLA WERE EXCHANGED. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE STABLE FOLLOWING THE EVENT. NO X-RAYS OR IMAGING WAS AVAILABLE. THE PRODUCT IS NOT AVAILABLE FOR RETURN AS IT WAS DISPOSED OF BY THE HOSPITAL. DEVICE IMAGES WERE PROVIDED. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590035 LOGIC SEE H10 JWH EXACTECH, INC. LOGIC TIBIAL INSERT SLOPE ++, SZ 2.5, 9 MM UNK 10885862159212

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Required Intervention SEE H10