BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC

    MDR report key: 15777282 · Received November 10, 2022

    Report

    Report Number
    1038671-2022-01449
    Event Type
    Injury
    Date Received
    November 10, 2022
    Date of Event
    January 25, 2022
    Report Date
    April 17, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862173669
    PMA / PMN Number
    K110547
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: B1, B2, H6 - HEALTH EFFECT - CLINICAL CODE, MEDICAL DEVICE PROBLEM CODE, COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS AND H11 THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO DEVICE WAS RETURNED FOR EVALUATION; FURTHER, PHOTOGRAPHS AND/OR RADIOGRAPH IMAGES WERE NOT PROVIDED FOR REVIEW. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED; HOWEVER, MAY HAVE BEEN THE RESULT OF PROSTHESIS WEAR, OSTEOLYSIS, AND INSUFFICIENT BONDS BETWEEN THE IMPLANT AND THE BONES WHICH LED TO ASEPTIC (NON-INFECTED) LOOSENING. POSSIBLE CAUSES FOR POLYETHYLENE WEAR INCLUDE MALALIGNMENT BETWEEN THE IMPLANTS, HIGH CONTACT STRESSES DURING KNEE FLEXION, THIRD BODY WEAR, PATIENT-RELATED CONDITIONS, INSTABILITY, OR ANY COMBINATION OF THESE POSSIBILITIES. 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

    CONCOMITANT MEDICAL PRODUCTS: 02-010-01-0340, LOGIC FEMORAL PS CEM RIGHT SZ 4, 4868915, 02-012-41-4040, LOGIC TIBIA TRAPTRAY CEM SZ 4F/4T, 4818907, 200-02-35, THREE PEG PATELLA 35MM, 4970560. ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION RESULTS - THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS WEAR, OSTEOLYSIS, AND INSUFFICIENT BONDS BETWEEN THE IMPLANT AND THE BONES WHICH LED TO ASEPTIC (NON-INFECTED) LOOSENING. POSSIBLE CAUSES FOR POLYETHYLENE WEAR INCLUDE MALALIGNMENT BETWEEN THE IMPLANTS, HIGH CONTACT STRESSES DURING KNEE FLEXION, THIRD BODY WEAR, PATIENT-RELATED CONDITIONS, INSTABILITY, OR ANY COMBINATION OF THESE POSSIBILITIES. THE EXTENT AND ROOT CAUSE OF THE PROSTHESIS WEAR, OSTEOLYSIS, AND LOOSENING COULD NOT BE DETERMINED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION, AND IMAGES AND RADIOGRAPHS WERE NOT PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA A LEGAL NOTIFICATION THAT A MALE PATIENT, INITIAL RIGHT KNEE IMPLANTED ON (B)(6) 2017, WAS REVISED ON (B)(6) 2022, APPROXIMATELY 4 YEARS 4 MONTHS POST THE INITIAL PROCEDURE. THE REPORTED INFORMATION INDICATED THAT IN THE MIDDLE OF 2020, THE PATIENT BEGAN EXPERIENCING SEVERE PAIN, SWELLING, AND INSTABILITY IN HIS RIGHT KNEE. AN MRI PERFORMED ON (B)(6) 2021, ON THE PATIENT¿S RIGHT KNEE DEMONSTRATED A ¿POLYMERIC-INDUCED SYNOVITIS¿, ¿FOCAL FEMORAL OSTEOLYSIS, AND PROMINENT FIBROUS INTERFACE OVER THE PATELLA COMPONENTS¿, ¿DEFICIENCY OF THE FIBULAR COLLATERAL LIGAMENT AND DEGENERATION OF THE POPLITEUS TENDON.¿ THE PATIENT'S CLINICAL, LABORATORY, AND RADIOLOGICAL WORKUP ON HIS RIGHT KNEE WAS NEGATIVE FOR INFECTION, BUT POSITIVE FOR LOOSENING SECONDARY TO OSTEOLYSIS SECONDARY TO POLYETHYLENE WEAR. NO DEVICE RETURNING DUE TO THIS BEING A LEGAL CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198847 LOGIC PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, JWH EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 15MM UNK 10885862173669

    Patients

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