BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC

    MDR report key: 15877848 · Received November 29, 2022

    Report

    Report Number
    1038671-2022-01521
    Event Type
    Injury
    Date Received
    November 29, 2022
    Date of Event
    June 3, 2022
    Report Date
    November 20, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862265678
    PMA / PMN Number
    K150890
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: 4694401 02-010-06-0541 - LOGIC POST. AUG. BLOCK SIZE 4, 5MM, 2916041 02-012-35-4017 - LOGIC PS TIB INS SZ 4 17MM, 2046914 02-012-45-4050 - LGC TIBIAL FIT TRAY CEM SZ 4F / 5T, 4562441 02-012-60-1480 - LOGIC STEM EXT 14MM X 80MM, 4539233 02-012-60-2080 - LOGIC STEM EXT 20MM X 80MM, 4690545 02-012-61-4000 - LOGIC OFFSET STEM EXT COUPLER 4MM, 5014271 02-012-61-4000 - LOGIC OFFSET STEM EXT COUPLER 4MM, 4996346 204-70-00 - TIBIAL STEM EXT. SCREW, 3984131 208-05-04 - CC DISTAL FEM AUGMENT SZ 4, 5MM, 4536864 208-06-04 - CC DISTAL FEM AUGMENT SZ 4, 10MM. (B)(4). ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    H6: THE REVISION REPORTED WAS LIKELY THE RESULT OF AN INSUFFICIENT BOND BETWEEN THE FEMORAL COMPONENT AND THE BONE AND/OR PATIENT-RELATED CONDITIONS, WHICH LED TO ASEPTIC (NON-INFECTED) FEMORAL LOOSENING, PAIN, AND INSTABILITY. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES OF THE EXPLANTED DEVICES/PRE-REVISION RADIOGRAPHS WERE NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION B5, G4 CORRECTED INFORMATION H6-HEALTH EFFECT CLINICAL CODE, MEDICAL DEVICE PROBLEM CODE.

    Additional Manufacturer Narrative · 0

    1038671-2024-04134. 1038671-2024-04133. A4: CORRECTED THE FOLLOWING: PATIENT WEIGHT. B1: CORRECTED THE FOLLOWING: TYPE OF REPORT (CHECK ALL THAT APPLY). B2: CORRECTED THE FOLLOWING: OUTCOMES ATTRIBUTED TO ADVERSE EVENT (CHECK ALL THAT APPLY). G1: CORRECTED THE FOLLOWING: REPORTING CONTACT NAME PREFIX/TITLE (DR., MRS., ETC.), REPORTING CONTACT FIRST NAME, REPORTING CONTACT LAST NAME. H6: CORRECTED THE FOLLOWING: COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION CONCLUSIONS. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF FEMORAL LOOSENING, BONE FRACTURE, AND PROSTHESIS WEAR 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, RADIOGRAPHS, AND RELEVANT CLINICAL INFORMATION WERE NOT PROVIDED. SHOULD ADDITIONAL RELEVANT INFORMATION BE OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 64 YO MALE PATIENT, INITIAL LEFT KNEE IMPLANTED ON (B)(6) 2017, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022, APPROXIMATELY 4 YEARS 7 MONTHS POST THE INITIAL PROCEDURE. THE SURGEON REVISED THE FEMORAL COMPONENTS FOR A LOGIC CC KNEE. THE FEMORAL COMPONENTS WERE LOOSE. THE TIBIAL COMPONENTS WERE WELL FIXED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE PRODUCT IS NOT RETURNING, NO REASON PROVIDED. NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 0

    THIS PATIENT WAS PART OF THE EXACTECH CC CLINICAL STUDY. THE PATIENT PRESENTED ON (B)(6), 2018, WITH A PATELLAR SLEEVE FRACTURE THAT PRESENTS AS CLICKING LATERALLY WITH FLEXION BUT IS NOT PAINFUL. INDICATION FOR REVISION SURGERY STATED ASEPTIC LOOSENING, INSTABILITY, AND PAIN/STIFFNESS. DATE OF ONSET WAS UNKNOWN. THE STUDY INDICATES THE EVENT IS POSSIBLY RELATED TO THE DEVICES AND THE PROCEDURE. THE FEMORAL, PATELLA, TIBIAL INSERT AND TRAY COMPONENTS WERE REVISED. THE STUDY INDICATES THE EVENT WAS RESOLVED ON THE SURGERY DATE. NO DEVICE RETURNED DUE TO CLINICAL STUDY GUIDELINES.

    Description of Event or Problem · 0

    THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A COORDINATED ACTION IN (B)(6) WITH MASTER CASE NO. (B)(4). THE CONSOLIDATED LONG FORM COMPLAINT THAT APPLIES TO CASES FILED IN THIS COORDINATED ACTION ALLEGES THAT PATIENTS FILING SUITS IN THIS COORDINATED ACTION WERE REQUIRED ¿TO UNDERGO REVISION SURGERIES DUE TO SEVERE, PAIN, SWELLING, AND INSTABILITY¿ DUE TO ¿WEAR OF THE POLYETHYLENE COMPONENTS AND RESULTING COMPONENT LOOSENING AND/OR OTHER FAILURE FAILURES CAUSING SERIOUS COMPLICATIONS INCLUDING TISSUE DAMAGE, OSTEOLYSIS, PERMANENT BONE LOSS, AND OTHER INJURIES.¿ BECAUSE THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN THIS COORDINATED ACTION, THE PATIENT APPEARS TO ALLEGE THAT THE PATIENT WAS INJURED AS A RESULT OF WEAR OF AN EXACTECH POLYETHYLENE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2535876 LOGIC PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, JWH EXACTECH, INC. LOGIC CC FEMORAL SIZE 4, LEFT UNK 10885862265678

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Hospitalization| R SEE H10