BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THREE PEG PATELLA 38MM

    MDR report key: 18467195 · Received January 8, 2024

    Report

    Report Number
    1038671-2024-00035
    Event Type
    Injury
    Date Received
    January 8, 2024
    Date of Event
    December 7, 2023
    Report Date
    May 21, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862039613
    PMA / PMN Number
    K932690
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS WEAR, OSTEOLYSIS, AND AN INSUFFICIENT BOND BETWEEN THE FEMORAL COMPONENT AND THE BONE, WHICH LED TO ASEPTIC (NON-INFECTED) FEMORAL LOOSENING. POSSIBLE CAUSES FOR POLYETHYLENE WEAR INCLUDE MALALIGNMENT BETWEEN THE IMPLANTS, HIGH CONTACT STRESSES DURING KNEE FLEXION, THIRD BODY WEAR, PATIENT-RELATED CONDITIONS, INSTABILITY, OR ANY COMBINATION OF THESE POSSIBILITIES. THE EXTENT AND ROOT CAUSE OF THE PROSTHESIS WEAR, OSTEOLYSIS, AND FEMORAL LOOSENING COULD NOT BE DETERMINED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 0

    SECTION D10: CONCOMITANT PRODUCTS LOGIC CR FEMORAL POR, LEFT, SZ 5 (CAT# 02-010-04-0250 / SERIAL# (B)(6)). LOGIC TIB INSERT IMPL CRC, SZ 5, 11MM (CAT# 02-012-51-5011 / SERIAL# (B)(6) - RECALL# Z-0021-2022). ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE REVISION REPORTED WAS LIKELY THE RESULT OF A WEAKENED BIOLOGIC INTEGRATION OF THE FEMORAL COMPONENT AT THE BONE-IMPLANT INTERFACE WHICH LED TO ASEPTIC (NON-INFECTED) FEMORAL LOOSENING. THE IMAGE OF THE TIBIAL INSERT SHOWED MINOR THIRD BODY WEAR BUT WAS LARGELY UNREMARKABLE FOR AN IMPLANTED DEVICE WITH NO EVIDENCE OF VOLUMETRIC WEAR. LOCALIZED DAMAGE WAS NOTED ON THE PATELLA LIKELY SECONDARY TO HIGH IN-VIVO PRESSURE FROM INSUFFICIENT SUPERIOR PATELLAR RESECTION. HOWEVER, THE EXTENT AND ROOT CAUSE OF THE PROSTHESIS WEAR, OSTEOLYSIS, AND FEMORAL LOOSENING COULD NOT BE DETERMINED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION. 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, APPROXIMATELY TWO YEARS POST INITIAL LEFT TKA, THE 53 Y/O MALE PATIENT WAS REVISED DUE TO PATELLA WEAR AND DELAMINATION. THE PATIENT WAS REVISED TO EXACTECH DEVICES A SIZE 5, 15 MM TIBIAL INSERT. THE FEMORAL COMPONENT WAS ALSO REVISED TO SIZE 5. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGES AND X-RAYS RECEIVED. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE TO THE DEVICES WERE DISPOSED AT HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675831 THREE PEG PATELLA 38MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. THREE PEG PATELLA 38MM UNK 10885862039613

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male Required Intervention LGC TIBIAL FIT TRAY CEM SZ 5F/4T.