BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA IMPLANT PSC INSERT, SZ 5, 11MM

    MDR report key: 19499617 · Received June 10, 2024

    Report

    Report Number
    1038671-2024-01845
    Event Type
    Injury
    Date Received
    June 10, 2024
    Date of Event
    December 1, 2022
    Report Date
    February 17, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862173720
    PMA / PMN Number
    K110547
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANT DEVICES: 3589451 200-02-38 - THREE PEG PATELLA 38MM 3857287 02-010-01-0250 - LOGIC FEMORAL PS CEM LEFT SZ 5 3883534 02-012-45-5050 - LGC TIBIAL FIT TRAY CEM SZ 5F / 5T. THE PRODUCT ASSOCIATED WITH THE REPORTED EVENT IS WITHIN THE SCOPE OF RECALL Z-0021-2022; HOWEVER, THERE IS INSUFFICIENT INFORMATION TO EVALUATE WHETHER THE SUBJECT ISSUE OF THE RECALL WAS THE CAUSE OR CONTRIBUTOR TO THE REPORTED EVENT. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO MEDICAL OR OTHER RECORDS CONTAINING TREATMENT INFORMATION OR PATIENT INFORMATION HAVE BEEN RECEIVED; THEREFORE, THE REPORTED EVENT CANNOT BE CONFIRMED, NOR CAN THE CIRCUMSTANCES OR POTENTIAL CAUSES OR CONTRIBUTORS TO THE ALLEGED EVENT BE EVALUATED. SHOULD ADDITIONAL MATERIAL INFORMATION BECOME AVAILABLE THAT PERMITS MORE ANALYSIS OR CONCLUSIONS, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY 92 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS ASEPTIC LOOSENING. THE PATIENT WAS INDICATED FOR SEVERE PAIN DUE TO FAILED ASEPTIC LOOSENING OF LEFT TOTAL KNEE REPLACEMENT. THE OPERATIVE REPORT INTRAOPERATIVE FINDINGS NOTE LOOSE FEMORAL IMPLANT REMOVED EASILY WITH MINIMAL BONE LOSS. THE BACKSIDE OF THE FEMORAL IMPLANT WAS 100% CLEAN WITHOUT ANY CEMENT ATTACHED. ALL OF THE CEMENT WAS ON THE DISTAL FEMUR. ON THE BACKSIDE OF THE CEMENT WAS SIGNIFICANT OSTEOLYSIS FROM POLY WEAR THAT HAD DESTROYED THE BONE. THERE WAS EXTENSIVE SOFT TISSUE DAMAGE THROUGHOUT THE KNEE JOINT AS A RESULT OF OSTEOLYSIS AS WELL. PATELLA BUTTON WAS WELL FIXED AND STABLE. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202327 LOGIC TIBIA IMPLANT PSC INSERT, SZ 5, 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862173720

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Required Intervention| H SEE H11