BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR FEMORAL POR, LEFT, SZ 4

    MDR report key: 18988700 · Received March 27, 2024

    Report

    Report Number
    1038671-2024-00681
    Event Type
    Injury
    Date Received
    March 27, 2024
    Date of Event
    September 13, 2022
    Report Date
    June 4, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862158277
    PMA / PMN Number
    K140302
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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, FEMORAL LOOSENING, INSTABILITY AND TIBIAL LOOSENING, AND PATELLAR 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 IMAGES AND RADIOGRAPHS WERE NOT PROVIDED. H6: CORRECTED HEALTH EFFECT, MEDICAL DEVICE, COMPONENT, AND INVESTIGATION CLINICAL CODES.

    Additional Manufacturer Narrative · 0

    D10. CONCOMITANTS: OPTETRAK LOGIC TIBIAL INSERT (02-012-51-4013, 4141935); OPTETRAK 3 PEG PATELLA (200-02-32, 6529350); OPTETRAK LOGIC FIT TIBIAL TRAY (02-022-45-4030, 5281680); PALACOS R&G BONE CEMENT X 2. H3. INVESTIGATION RESULTS- THE CAUSE OF THE PATIENT¿S INFECTION/SEPTIC LOOSENING AND SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION AS ASSOCIATED WITH THE INTERACTION BETWEEN THE IMPLANTED DEVICE AND THE PATIENT DUE TO PATIENT ILLNESS, UNIQUE ANATOMY, OR OTHER CONDITION THAT IMPACTS THE PERFORMANCE OF THE DEVICE. THERE IS NO CLINICAL/PATIENT MEDICAL INFORMATION PROVIDED. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. THERE IS NO OTHER INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2020 AND THEN APPROXIMATELY 1 YEAR, 9 MONTHS LATER ON (B)(6) 2022 THE PATIENT EXPERIENCED A REVISION SURGICAL PROCEDURE. THE PATIENT WAS REVISED TO COMPETITOR DEVICES. REVISION OPERATIVE REPORT OF 26 APR 2022- FAILED TKA SECONDARY SEPTIC LOOSENING. X-RAYS DEMONSTRATED LOOSENING OF TIBIAL AS WELL AS PATELLAR COMPONENT. ASPIRATED KNEE, IT WAS SIGNIFICANT FOR RED BLOOD CELLS AS WELL AS 12,000 WHITE BLOOD CELLS WITH 100% NEUTROPHIL DIFFERENTIAL- NOTHING GREW FROM THE ASPIRATION. PATELLAR COMPONENT WAS COMPLETELY LOOSE. REMOVED ANY REMAINING CEMENT. FEMORAL COMPONENT WAS GROSSLY LOOSE. REMOVED IT AS WELL AS THE FIBROUS TISSUE UNDERNEATH IT ALL THE WAY BACK TO BONE. REMOVED THE TIBIAL COMPONENT, IT WAS GROSSLY LOOSE. STERILE DRESSING WAS APPLIED. NO APPARENT COMPLICATIONS NOTED. THERE IS NO CLINICAL/PATIENT MEDICAL INFORMATION PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468078 LOGIC CR FEMORAL POR, LEFT, SZ 4 PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862158277

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Required Intervention SEE H10