BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA IMPLANT PSC INSERT, SZ 1, 9MM

    MDR report key: 21484448 · Received February 27, 2025

    Report

    Report Number
    1038671-2025-01314
    Event Type
    Injury
    Date Received
    February 27, 2025
    Date of Event
    November 14, 2022
    Report Date
    March 18, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    PMA / PMN Number
    K110547
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: H6 MDR SECTION CODES UPDATED/CORRECTED: B, C, E THE REVISION REPORTED WAS LIKELY THE REPORT OF PROSTHESIS WEAR AND AN INSUFFICIENT BOND BETWEEN THE IMPLANTS AND THE BONE, 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 AND LOOSENING COULD NOT BE DETERMINED AS THE DEVICES WERE NOT RETURNED 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 (B)(6), 02-010-01-0210 - LOGIC FEMORAL PS CEM LEFT SZ 1, (B)(6), 02-012-41-1010 - LOGIC TIBIA TRAPTRAY CEM SZ 1F/1T, (B)(6) , 200-02-32 - THREE PEG PATELLA 32MM. 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. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 131 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING AND CHRONIC PAIN. INITIAL SURGERY AND REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. POST OPERATIVE DIAGNOSIS NOTED MECHANICAL LOOSENING. INTRAOPERATIVELY THE SURGEON OBSERVED SYNOVITIS, LAXITY, SIGNIFICANT POLYETHYLENE INSERT WEAR, OSTEOLYSIS, OSTEOPHYTES AND POPLITEAL CYST. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. 02-012-44-1009 - LOGIC TIBIA IMPLANT PSC INSERT, SZ 1, 9MM SERIAL: (B)(6), 510K: K110547, UDI: (B)(4), PRODUCT CODE: JWH, X-RAY: NO, OPERATIVE NOTES: YES. ORIGINAL SUMMARY LEGAL CASE - (B)(6). AS REPORTED BY THE LEGAL BRIEF, ON OR ABOUT (B)(6) 2012, PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY DUE TO OSTEOARTHRITIS IN HER LEFT KNEE. IN APPROXIMATELY (B)(6) 2022, PATIENT PRESENTED TO HOSPITAL FOR AN EVALUATION OF HER LEFT KNEE, AS SHE HAD BEEN COMPLAINING OF MECHANICAL COMPLICATIONS AND CHRONIC PAIN. ON OR ABOUT (B)(6) 2022, PATIENT UNDERWENT REVISION SURGERY OF HER LEFT KNEE DUE TO IMPLANT LOOSENING AND SIGNIFICANT SYNOVITIS. THE REVISION REPORTED IN (B)(4) WAS LIKELY THE REPORT OF PROSTHESIS WEAR AND AN INSUFFICIENT BOND BETWEEN THE IMPLANTS AND THE BONE, 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 AND LOOSENING COULD NOT BE DETERMINED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION, AND IMAGES AND RADIOGRAPHS WERE NOT PROVIDED. CONCOMITANT PRODUCTS: LOGIC TIBIA TRAPTRAY CEM SZ 1F/1T (CAT# 02-012-41-1010 / SERIAL# (B)(6), THREE PEG PATELLA 32MM (CAT# 200-02-32 / SERIAL# (B)(6), LOGIC TIBIA IMPLANT PSC INSERT, SZ 1, 9MM (CAT# 02-012-44-1009 / SERIAL# (B)(6). 510K: K033883 SERIAL NUMBER (B)(6) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. MANUFACTURED: 07/18/11, EXPIRATION DATE: 06/18/19.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690615 LOGIC TIBIA IMPLANT PSC INSERT, SZ 1, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Required Intervention| H SEE H11