BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA IMPLANT PSC INSERT, SZ 2, 11MM

    MDR report key: 13419284 · Received February 1, 2022

    Report

    Report Number
    1038671-2022-00123
    Event Type
    Injury
    Date Received
    February 1, 2022
    Date of Event
    April 7, 2021
    Report Date
    January 3, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    PMA / PMN Number
    K110547
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    THE REVISION REPORTED WAS LIKELY THE RESULT OF AN INSUFFICIENT BOND BETWEEN THE IMPLANT AND THE BONE, WHICH LED TO ASEPTIC (NON-INFECTED) LOOSENING. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND PRE-REVISION X-RAYS WERE NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. H3: THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF FEMORAL LOOSENING, PROSTHESIS WEAR, AND/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: ANNEX "D" CODE.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 3.14 YEARS POST LEFT SIDE TKA, THIS FEMALE PATIENT UNDERWENT REVISION DUE TO ASEPTIC LOOSENING. NO ADDITIONAL INFORMATION IS AVAILABLE OR FORTHCOMING. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. 510K: K110547.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FROM A LEGAL NOTIFICATION. PREOP DIAGNOSIS ¿ LEFT KNEE FEMORAL LOOSENING, OSTEOLYSIS. FINDINGS: GROSSLY LOOSE FEMUR COMPONENT, FEMORAL OSTEOLYSIS, WELL FIXED PATELLA AND TIBIA. INTRAOPERATIVE FROZEN SECTION NOT CONSISTENT WITH INFECTION. PATIENT PRESENTED TO CLINIC WITH LEFT KNEE PAIN. WORK UP REVEALED FEMORAL LOOSENING; C ACNES GREW OUT ON ONE CULTURE IN BROTH ONLY. BELIEVED THIS WAS MOST LIKELY A CONTAMINANT. DECISION TO PROCEED WITH REVISION TKA GIVEN THE PATIENT¿S SIGNIFICANT PAIN. THE FEMORAL COMPONENT WAS FOUND TO BE GROSSLY LOOSE AND WAS EASILY REMOVED WITH A TAMP. THERE WAS EXTENSIVE OSTEOLYSIS OF THE POSTERIOR AND DISTAL FEMORAL CONDYLES LATERALLY AND MEDIALLY. THE TIBIAL COMPONENT WAS FOUND TO BE WELL FIXED. THE PATELLA WAS WELL FIXED AND TRACKED WELL AND WAS NOT REVISED. THE PATIENT¿S OTHER COMPONENTS WERE REVISED TO A COMPETITOR¿S DEVICES. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1498034 LOGIC TIBIA IMPLANT PSC INSERT, SZ 2, 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 2, 11MM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention