BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT STD, SZ 2, 13MM

    MDR report key: 17321038 · Received July 13, 2023

    Report

    Report Number
    1038671-2023-01654
    Event Type
    Injury
    Date Received
    July 13, 2023
    Date of Event
    July 8, 2022
    Report Date
    January 3, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862174260
    PMA / PMN Number
    K111400
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. D10. CONCOMITANTS: 02-010-03-0220 - LOGIC CR FEMORAL CEM, LEFT SZ 2; 4933710, 02-012-45-2020 - LGC TIBIAL FIT TRAY CEM SZ 2F / 2T; 5171781, 200-02-29 - THREE PEG PATELLA 29MM; 4048696.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: G3, H6. THE FOLLOWING SECTIONS WERE CORRECTED: H6. MDR SECTION CODES UPDATED/CORRECTED: B, C, D, E, G. THE REASON FOR THE REVISION REPORTED IN CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. ADDITIONALLY, A CONTRIBUTING FACTOR TO THE REPORTED WEAR MAY HAVE BEEN THE RESULT OF BEING PACKAGED IN A NON-CONFORMING VACUUM BAG FOR MORE THAN FIVE YEARS. 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, A PATIENT HAD LEFT KNEE REPLACEMENT ON (B)(6) 2018. THEY SUBSEQUENTLY UNDERWENT LEFT KNEE REVISION ON (B)(6) 2022, APPROXIMATELY 7 YEARS 2 MONTHS AFTER THEIR INITIAL IMPLANTATION. ON (B)(6) 2022 OP REPORT NOTED SIGNIFICANT SEROUS FLUID IDENTIFIED IN THE KNEE AND SIGNIFICANT SYNOVIAL HYPERTROPHY AND INFLAMMATION. THE POLYETHYLENE HAD SIGNIFICANT EROSION AND DELAMINATION AFFECTING THE MEDIAL AND THE POSTERIOR QUARTER OF THE POLYETHYLENE LINER. ALL COMPONENTS WERE SOLIDLY FIXED. THERE WAS MINIMAL EROSION MEDIALLY ON THE TIBIAL TRAY BUT WAS EXTREMELY STABLE. THE PATIENT TOLERATED THE PROCEDURE QUITE NICELY. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765549 LOGIC CR TIB INSERT STD, SZ 2, 13MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED JWH EXACTECH, INC. 02-012-47-2013 UNK 10885862174260

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention