BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LGC TIBIAL FIT TRAY CEM SZ 4F / 5T

    MDR report key: 19822726 · Received July 24, 2024

    Report

    Report Number
    1038671-2024-02511
    Event Type
    Injury
    Date Received
    July 24, 2024
    Date of Event
    January 24, 2024
    Report Date
    December 23, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    PMA / PMN Number
    K101981
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10. RELATED: MFR #1038671-2024-02509 REPORT 1 OF 3. MFR #1038671-2024-02510 REPORT 2 OF 3. H11. ADDITIONAL MANUFACTURER NARRATIVE- REPORT 3 OF 3. D10. CONCOMITANT DEVICES: 4590127, 02-010-03-0340 - LOGIC CR FEMORAL CEM, RIGHT, SZ 4. 4638500, 200-02-32 - THREE PEG PATELLA 32MM. 2082352, 02-012-49-4009 - LOGIC CR TIB INSERT SLOPE++, SZ 4, 9MM. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. THERE IS NO ADDITIONAL INFORMATION AVAILABLE. PENDING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    1038671-2024-02510, 1038671-2024-02509 THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 1038671-2024-02510, 1038671-2024-02509. THE FOLLOWING SECTIONS WERE UPDATED: H6. THE FOLLOWING SECTIONS WERE CORRECTED: B1, B2, D1, D4, H6. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR, FEMORAL LOOSENING, TIBIAL LOOSENING AND/OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. ADDITIONALLY, A CONTRIBUTING FACTOR TO THE REPORTED WEAR MAY HAVE BEEN THE RESULT OF BEING PACKAGED IN A NON-CONFORMING VACUUM BAG FOR MORE THAN FIVE YEARS. 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

    AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY AND THEN APPROXIMATELY 7 YEARS LATER EXPERIENCED A REVISION SURGERY. REVISION OPERATIVE REPORT OF (B)(6) 2024: PREOPERATIVE DIAGNOSES: 1. FAILED RIGHT TOTAL KNEE REPLACEMENT SECONDARY TO POLYETHYLENE BREAKDOWN AND SUBSEQUENT CYSTIC CHANGES TO BOTH THE FEMUR AND THE TIBIA, RESULTING IN LOOSENING OF THE RIGHT TOTAL KNEE PROSTHESIS. 2. CHRONIC RIGHT KNEE PAIN AS A RESULT OF DIAGNOSIS #1. THE PATIENT WAS REVISED TO COMPETITOR¿S DEVICES. THE RIGHT KNEE CLINICALLY AND RADIOGRAPHICALLY DEMONSTRATES FAILURE. HARDWARE REMOVED: AN EXACTECH TOTAL KNEE REPLACEMENT SYSTEM WAS REMOVED. AT THE TIME OF THE REMOVAL, THERE WAS GROSS LOOSENING OF THE FEMORAL AND TIBIAL COMPONENTS. THERE WERE CYSTIC DEGENERATIVE CHANGES THROUGHOUT THE TIBIA AND WITHIN THE FEMUR BOTH MEDIALLY AND LATERALLY, AND THERE WAS COMPLETE BREAKDOWN OF THE POSTEROMEDIAL TIBIAL TRAY WITH SUBSEQUENT METALLOSIS FROM METAL-ON-METAL CONTACT OF THE FEMORAL COMPONENT ON THE TIBIAL COMPONENT, RESULTING IN METALLOSIS VILLONODULAR SYNOVITIS THROUGHOUT THE KNEE. ENCOUNTERED VILLONODULAR SYNOVITIS CLASSICALLY SEEN WITH METALLOSIS THAT WAS BLACKENED IN COLOR. VILLONODULAR SYNOVITIC CHANGES IN THE UNDERSIDE OF THE BONE OF THE PATELLA WHERE CYSTIC DEGENERATIVE CHANGES FROM POLYETHYLENE WEAR DEBRIS HAD BEEN OCCURRING. THE PATIENT WAS AWAKENED AND EXTUBATED AND TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. THERE WERE NO INTRAOPERATIVE COMPLICATIONS. THERE IS NO OTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2482233 LGC TIBIAL FIT TRAY CEM SZ 4F / 5T PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention| H SEE H11