BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC FEMORAL PS CEM LEFT SZ 3.5

    MDR report key: 17073193 · Received June 6, 2023

    Report

    Report Number
    1038671-2023-01258
    Event Type
    Injury
    Date Received
    June 6, 2023
    Date of Event
    May 5, 2023
    Report Date
    February 25, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001153
    PMA / PMN Number
    K033883
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. D10: 2504778, 02-012-35-3513 - LOGIC TIBIA PS MOD INSRT SZ 3.5 13MM. 4159884, 204-34-02 - FLUTED STEM EXTENSION 25L X 14 MM. 4250804, 02-012-45-3525 - LGC TIBIAL FIT TRAY CEM SZ 3.5F / 2.5T. 4279787, 200-02-32 - THREE PEG PATELLA 32MM. 4285661, 204-70-00 - TIBIAL STEM EXT. SCREW. H7: Z-0021-2022 FOR 2504778. 02-012-35-3513 - LOGIC TIBIA PS MOD INSRT SZ 3.5 13MM.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO DEVICE WAS RETURNED FOR EVALUATION; FURTHER, PHOTOGRAPHS AND/OR RADIOGRAPH IMAGES WERE NOT PROVIDED FOR REVIEW. THE REASON FOR THE REVISION REPORTED MAY BE THE RESULT OF PROSTHESIS WEAR, TIBIAL LOOSENING, AND FEMORAL LOOSENING OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND RADIOGRAPHS WERE NOT PROVIDED. THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: D10, H6 CLINICAL CODE. D10: (B)(6) 204-34-02 - FLUTED STEM EXTENSION 25L X 14 MM. (B)(6) 200-02-32 - THREE PEG PATELLA 32MM. (B)(6) 204-70-00 - TIBIAL STEM EXT. SCREW.

    Description of Event or Problem · 0

    AS REPORTED, THE PATIENT HAD AN INITIAL LEFT TKA ON (B)(6) 2016. THIS CASE WAS SCHEDULED AS JUST A POLY EXCHANGE DUE TO THE RECALL. ONCE THE SURGEON DISSECTED DOWN HE REALIZED THE FEMUR WAS FALLING OFF AND THERE WAS LOTS OF OSTEOLYSIS, SO HE REVISED TO COMPETITOR'S DEVICES. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746222 LOGIC FEMORAL PS CEM LEFT SZ 3.5 PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. 02-010-01-0235 10885862001153

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female Required Intervention SEE H10.| SEE H11.