BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THREE PEG PATELLA 35MM

    MDR report key: 20605819 · Received November 4, 2024

    Report

    Report Number
    1038671-2024-04228
    Event Type
    Injury
    Date Received
    November 4, 2024
    Date of Event
    October 21, 2024
    Report Date
    January 27, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862039606
    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

    (H3) PENDING EVALUATION (D10) CONCOMITANT DEVICE(S): (B)(6) - GPS IMPLANT KIT V2 12001017021, 02-010-03-0220 - LOGIC CR FEMORAL CEM, LEFT SZ 2 3602834, 521-78-32 - THREADED PIN SIZE 3.0 COLLARLESS 4931515, 02-012-45-2020 - LGC TIBIAL FIT TRAY CEM SZ 2F / 2T 5106006, 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK 5192214, 521-78-23 - THREADED PIN SIZE 2.3 COLLARED 5197802, 521-78-23 - THREADED PIN SIZE 2.3 COLLARED 5197881, 201-78-81 - 3 TROCAR, MOD. HEX 2PK 5269090.

    Additional Manufacturer Narrative · 0

    REPORT NUMBER: 1038671-2024-04229 THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 1038671-2024-04229. THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS WEAR OF THE TIBIAL INSERT AND PATELLA SECONDARY TO CONTRIBUTIONS FROM INSTABILITY AND/OR COMBINED TIBIAL SLOPE LEADING TO ARTICULATION OF THE FEMORAL COMPONENT ON THE POSTERIOR EDGE OF THE TIBIAL INSERT AND ACCELERATED WEAR. THE REPORTED FAILURE OF LOOSENING CANNOT BE CONFIRMED FROM THE AVAILABLE INFORMATION. HOWEVER, THE CONTRIBUTIONS OF LOOSENING AND PROSTHESIS WEAR TO THE SEQUENCE OF EVENTS CANNOT BE DETERMINED AS THE DEVICES WERE NOT AVAILABLE 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

    IT WAS REPORTED THAT THIS PATIENT'S KNEE WAS REVISED APPROXIMATELY 6 YEARS 7 MONTHS POST OP. EVERYTHING WAS REVISED DUE TO WEAR ON PATELLA AND TIBIAL INSERT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50558 THREE PEG PATELLA 35MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862039606

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Hospitalization| R SEE H11