BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA IMPLANT PSC INSERT, SZ 3.5, 9MM

    MDR report key: 18312252 · Received December 12, 2023

    Report

    Report Number
    1038671-2023-02963
    Event Type
    Injury
    Date Received
    December 12, 2023
    Date of Event
    July 20, 2023
    Report Date
    December 10, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862173591
    PMA / PMN Number
    K110547
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITENTS: (B)(6)- 02-020-11-0335 - TRULIANT PS CEM FEM PS CEM RIGHT SZ 3.5. (B)(6)- 02-022-45-3535 - TRULIANT TIB FIT TRAY CEM SZ 3.5F / 3.5T. (B)(6)- A10012 - GPS IMPLANT KIT V2. PENDING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    RECALL NUMBER: Z-0021-2022 THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. 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 A CAUSE OR CONTRIBUTOR TO THE REPORTED EVENT. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 1038671-2024-04733 THE FOLLOWING SECTIONS WERE UPDATED: G1, H6. THE FOLLOWING SECTIONS WERE CORRECTED: B1, B2, G1, H6. D10: CONCOMITENTS: (B)(6) 02-020-11-0335 - TRULIANT PS CEM FEM PS CEM RIGHT SZ 3.5. (B)(6) 02-022-45-3535 - TRULIANT TIB FIT TRAY CEM SZ 3.5F / 3.5T. (B)(6) A10012 - GPS IMPLANT KIT V2. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR AND LOOSENING 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 KNEE REPLACEMENT ON (B)(6)2020. APPROXIMATELY 2 YEARS AND 9 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2023. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE. REVISION OP REPORT ON (B)(6) 2023. DIAGNOSIS: RK POLYETHYLENE WEAR AND OSTEOLYSIS WITH LOOSENING THE POLYETHYLENE COMPONENT WAS REMOVED AND NOTED TO HAVE MODERATE WEAR MORE THAN EXPECTED FOR THE AGE OF IMPLANT. IT WAS ALSO NOTED TO HAVE SIGNIFICANT SYNOVITIS CONSISTENT WITH POLYETHYLENE WEAR. A SYNOVECTOMY WAS PERFORMED IN ALL COMPARTMENTS TO REMOVE THE AFFECTED TISSUE. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN SATISFACTORY CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1213853 LOGIC TIBIA IMPLANT PSC INSERT, SZ 3.5, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK 10885862173591

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Unknown Required Intervention| H SEE H10