BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR FEMORAL CEM, LEFT, SZ 6

    MDR report key: 20157527 · Received September 6, 2024

    Report

    Report Number
    1038671-2024-03337
    Event Type
    Injury
    Date Received
    September 6, 2024
    Date of Event
    August 17, 2024
    Report Date
    March 5, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862158055
    PMA / PMN Number
    K121307
    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): 3984412, 02-012-45-6050 - LGC TIBIAL FIT TRAY CEM SZ 6F/5T. 4514319, 200-02-41 - THREE PEG PATELLA 41MM. 5967764, 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK. 5880731, 521-78-23 - THREADED PIN SIZE 2.3 COLLARED. 5880749, 521-78-23 - THREADED PIN SIZE 2.3 COLLARED. S018416, 521-78-23 - THREADED PIN SIZE 2.3 COLLARED. 5897278, 521-78-32 - THREADED PIN SIZE 3.0 COLLARLESS. S013354, 521-78-32 - THREADED PIN SIZE 3.0 COLLARLESS. S014710, 521-78-36 - THREADED PIN SIZE 5.1 COLLARLESS. 02029019128, A10012 - GPS IMPLANT KIT V2.

    Additional Manufacturer Narrative · 0

    "THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE REVISION REPORTED MAY HAVE BEEN THE RESULT OF FEMORAL LOOSENING AND PROSTHESIS WEAR. THE SUSPECTED LOOSENING MAY HAVE BEEN DUE TO AN INSUFFICIENT BOND BETWEEN THE IMPLANT AND THE BONE WHICH LED TO ASEPTIC (NON-INFECTED) LOOSENING OF THE FEMORAL COMPONENT. THE PROSTHESIS WEAR MAY HAVE BEEN DUE TO INCREASED LOADING TO THE POSTERIOR LATERAL ASPECT OF THE INSERT. HOWEVER, THIS CANNOT BE CONFIRMED AND POTENTIAL CONTRIBUTIONS OF USER OR PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND NO RADIOGRAPHS OR RELEVANT CLINICAL INFORMATION WAS PROVIDED. ADDITIONALLY, A CONTRIBUTING FACTOR TO THE PROSTHESIS WEAR MAY HAVE BEEN THE INSERT BEING PACKAGING IN A NON-CONFORMING BAG FOR MORE THAN 5 YEARS. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY."

    Additional Manufacturer Narrative · 0

    H3: THE REVISION REPORTED MAY HAVE BEEN THE RESULT OF FEMORAL LOOSENING AND PROSTHESIS WEAR. THE SUSPECTED LOOSENING MAY HAVE BEEN DUE TO AN INSUFFICIENT BOND BETWEEN THE IMPLANT AND THE BONE WHICH LED TO ASEPTIC (NON-INFECTED) LOOSENING OF THE FEMORAL COMPONENT. THE PROSTHESIS WEAR MAY HAVE BEEN DUE TO INCREASED LOADING TO THE POSTERIOR LATERAL ASPECT OF THE INSERT. HOWEVER, THIS CANNOT BE CONFIRMED AND POTENTIAL CONTRIBUTIONS OF USER OR PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND NO RADIOGRAPHS OR RELEVANT CLINICAL INFORMATION WAS PROVIDED. ADDITIONALLY, A CONTRIBUTING FACTOR TO THE PROSTHESIS WEAR MAY HAVE BEEN THE INSERT BEING PACKAGING IN A NON-CONFORMING BAG FOR MORE THAN 5 YEARS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS MALE PATIENT'S LEFT KNEE WAS REVISED DUE TO SUSPECTED IMPLANT LOOSENING IN FEMUR AND POLY WEAR/ LYSIS. EVERYTHING WAS REMOVED. PATIENT WAS NOT REVISED TO EXACTECH DEVICES. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PRODUCT NOT RETURNING: DISCARDED AT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1864764 LOGIC CR FEMORAL CEM, LEFT, SZ 6 PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862158055

    Patients

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