BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC FEMORAL PS CEM LEFT SZ 3

    MDR report key: 20014746 · Received August 21, 2024

    Report

    Report Number
    1038671-2024-02912
    Event Type
    Injury
    Date Received
    August 21, 2024
    Date of Event
    July 29, 2024
    Report Date
    April 10, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001146
    PMA / PMN Number
    K033883
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR, INSTABILITY, DEVICE-DEVICE LOOSENING, FAILURE OF THE CEMENT USED TO SECURE THE FEMORAL COMPONENT TO THE FEMORAL BONE, WHICH LED TO LOOSENING AT THE CEMENT-IMPLANT INTERFACE, AND PATELLAR LOOSENING OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. ADDITIONALLY, THESE DEVICES APPEAR TO HAVE BEEN IMPLANTED FOR OVER TEN YEARS PRIOR TO THE REPORTED EVENT. 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. H6: CORRECTED HEALTH EFFECT, MEDICAL DEVICE, COMPONENT, AND INVESTIGATION CLINICAL CODES.

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANT DEVICES: 2046556 02-012-35-3013 - LOGIC TIBIA PS MOD INSRT SZ 3 13MM 02-012-41-3032 OR 3033 - LOGIC TIBIA TRAPTRAY CEM SZ 3F/2T 200-02-35 OR 38 - THREE PEG PATELLA 35MM OR 38 MM THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO MEDICAL OR OTHER RECORDS CONTAINING TREATMENT INFORMATION OR PATIENT INFORMATION HAVE BEEN RECEIVED; THEREFORE, THE REPORTED EVENT CANNOT BE CONFIRMED, NOR CAN THE CIRCUMSTANCES OR POTENTIAL CAUSES OR CONTRIBUTORS TO THE ALLEGED EVENT BE EVALUATED. SHOULD ADDITIONAL, MATERIAL INFORMATION BECOME AVAILABLE THAT PERMITS MORE ANALYSIS OR CONCLUSIONS, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY 150 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, OSTEOLYSIS, SYNOVITIS, LOOSENING, DEBONDING, AORI TYPE 2B BONE LOSS. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2362499 LOGIC FEMORAL PS CEM LEFT SZ 3 PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862001146

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R SEE H11