BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIB INSERT IMPL CRC, SZ 2, 9MM

    MDR report key: 17109289 · Received June 12, 2023

    Report

    Report Number
    1038671-2023-01321
    Event Type
    Injury
    Date Received
    June 12, 2023
    Date of Event
    March 27, 2023
    Report Date
    February 11, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862230324
    PMA / PMN Number
    K123342
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2B: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER. D10. CONCOMITANTS: 3971218 200-05-26 - INSET PATELLA 26MM. 4207918 02-012-45-2030 - LGC TIBIAL FIT TRAY CEM SZ 2F / 3T. 4575936 02-010-03-0320 - LOGIC CR FEMORAL CEM, RIGHT, SZ 2. PENDING INVESTIGATION. NO OTHER INFORMATION IS AVAILABLE.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR AND INSTABILITY 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. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY."

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD AN INITIAL LEFT RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2017 AND THEN APPROXIMATELY 6 YEARS, 2 MONTHS LATER, ON (B)(6) 2023, THEY EXPERIENCED A REVISION SURGERY. REVISION OPERATIVE REPORT OF (B)(6) 2023. POSTOPERATIVE DIAGNOSIS: PAINFUL RIGHT KNEE ARTHROPLASTY. PATIENT PRESENTED WITH PAIN, INSTABILITY THIS WAS WORSENING OVER TIME. CLINICAL EXAMINATION IMAGING WAS CONSISTENT WITH POSSIBLE SYMPTOMATIC POLYETHYLENE WEAR. THERE WAS NO EVIDENCE OF PURULENCE. THERE WAS A SMALL EFFUSION, THERE WAS WHITE SYNOVITIS INVOLVING THE KNEE WHICH CAN BE SEEN WITH POLY WEAR. NO LOOSENING/INSTABILITY OF THE FEMORAL OR TIBIAL COMPONENTS. THERE WAS A SMALL AMOUNT OF OSTEOLYSIS EVIDENT ALONG THE LATERAL MARGIN OF THE FEMUR. THERE WAS SIGNIFICANT WEAR INVOLVING THE ANTERIOR ASPECT OF THE PATELLA. THERE WAS ENOUGH WEAR OF THE PATELLA THAT IT COULD POTENTIALLY CAUSE SOME PARTICLE DISEASE. PATELLA COMPONENT WAS REVISED. STERILE DRESSING WAS APPLIED, AND THE PATIENT WAS TRANSFERRED TO RECOVERY INSTABLE CONDITION. PATIENT WILL FOLLOW UP WITH ORTHOPEDIC CLINIC 2 WEEKS POST OP. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1330502 LOGIC TIB INSERT IMPL CRC, SZ 2, 9MM SEE H10 JWH EXACTECH, INC. 02-012-51-2009 10885862230324

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R