BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA IMPLANT PSC INSERT, SZ 6, 11MM

    MDR report key: 18990478 · Received March 28, 2024

    Report

    Report Number
    1038671-2024-00686
    Event Type
    Injury
    Date Received
    March 28, 2024
    Date of Event
    October 27, 2023
    Report Date
    November 27, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862173843
    PMA / PMN Number
    K110547
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    REPORT NUMBER: 1038671-2024-04518 THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: H10. THE FOLLOWING SECTIONS WERE CORRECTED: B2- BOTH HOSPITALIZATION - INITIAL OR PROLONGED AND REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE (DEVICES). THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR, CRACKING, AND FEMORAL 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. 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

    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, CRACKING, AND FEMORAL 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. 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

    D10. CONCOMITANTS: 2312320; 02-010-01-0360 - LOGIC FEMORAL PS CEM RIGHT SZ 6. 3859226; 02-012-45-6050 - LGC TIBIAL FIT TRAY CEM SZ 6F / 5T, 4060041; 200-02-38 - THREE PEG PATELLA 38MM. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. PENDING INVESTIGATION. THERE IS NO OTHER INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2015 AND THEN APPROXIMATELY 8 YEARS LATER ON (B)(6) 2023 EXPERIENCED A SURGICAL REVISION. REVISION OPERATIVE REPORT OF (B)(6) 2023 -POSTOPERATIVE DIAGNOSIS- FAILED RIGHT TOTAL KNEE/REVISION RIGHT TOTAL KNEE (TIBIAL, FEMORAL AND POLYETHYLENE COMPONENTS). PATIENT WAS REVISED TO COMPETITOR'S DEVICES. FINDINGS: LOOSE FEMORAL IMPLANT- REMOVED EASILY WITH MODERATE BONE LOSS. EXCESSIVE WEAR OF POLYETHYLENE WITH SIGNS OF OXIDATION/YELLOW DISCOLORATION, PITTING, CRACKING AND DELAMINATION OF THE POLY. DISTAL FEMORAL BONE LOSS WAS MODERATE. THE TIBIAL BONE LOSS WAS EXTENSIVE AND REPAIRED WITH TIBIAL CONE. PATELLA BUTTON WAS STABLE AND NOT REVISED. PATIENT WAS TAKEN TO PACU IN STABLE CONDITION. THERE IS NO OTHER PATIENT OR MEDICAL INFORMATION PROVIDED. NO DEVICE RETURN. THERE IS NO OTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716299 LOGIC TIBIA IMPLANT PSC INSERT, SZ 6, 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862173843

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention| H SEE H10.