BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSERT TIBIA LOGIC PSC SZ3 9MM

    MDR report key: 10382572 · Received August 7, 2020

    Report

    Report Number
    1038671-2020-00400
    Event Type
    Injury
    Date Received
    August 7, 2020
    Date of Event
    December 18, 2019
    Report Date
    January 30, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862173553
    PMA / PMN Number
    K110547
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER REVIEW OF ADDITIONAL INFORMATION RECEIVED THE FOLLOWING SECTIONS G3, G4, G7, H2 AND H3 HAVE BEEN UPDATED ACCORDINGLY. (H3) UPON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT A DESIGN OR MANUFACTURING ISSUE CAUSED OR CONTRIBUTED TO THIS EVENT. THE REPORTED REVISION WAS LIKELY THE RESULT OF UNDERLYING PATIENT FACTORS, WHICH LED TO INSTABILITY OF THE JOINT. PER IFU# 700-096-004 INSTABILITY IS A KNOWN COMPLICATION FOLLOWING TOTAL KNEE REPLACEMENT SURGERY AND IS MULTIFACTORIAL IN NATURE. INSTABILITY IS LISTED AS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH TOTAL JOINT REPLACEMENT SURGERY IN THE PRODUCT IFU (700-096-004). AS NOTED IN WHY ARE TOTAL KNEE ARTHROPLASTIES FAILING TODAY¿HAS ANYTHING CHANGED AFTER 10 YEARS? (SHARKEY, P. L. (2014S, SEPTEMBER). THE JOURNAL OF ARTHROPLASTY, 29), INSTABILITY IS IN THE TOP FIVE REASONS FOR THAT ACCOUNT FOR APPROXIMATELY 85% OF TOTAL KNEE REVISIONS (7.35% OF REVISIONS ARE FOR INSTABILITY).

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION CORRECTION - 510K K110547.

    Additional Manufacturer Narrative · 0

    H3: INVESTIGATION RESULTS - THE REVISION REPORTED WAS LIKELY THE RESULT OF DETACHMENT OF THE TIBIAL INSERT FROM THE TIBIAL TRAY AND AN INSUFFICIENT BOND BETWEEN THE FEMORAL COMPONENT AND THE BONE WHICH LED TO ASEPTIC (NON-INFECTED) FEMORAL LOOSENING. THE EXTENT AND ROOT CAUSE OF THE DEVICE DETACHMENT AND FEMORAL LOOSENING COULD NOT BE DETERMINED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION, AND IMAGES AND RADIOGRAPHS WERE NOT PROVIDED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED VIA LEGAL DEPARTMENT- REVISION OPERATIVE REPORT OF (B)(6) 2019- RIGHT KNEE MECHANICAL INSTABILITY. PATIENT WAS REVISED TO COMPETITOR¿S DEVICES. HISTORY- PATIENT PRESENTED WITH RIGHT KNEE PAIN AND INSTABILITY. PROCEDURE: THERE WAS NOTABLE SYNOVITIS. THE PATELLA WAS FOUND WELL FIXED. THE POLYETHYLENE WAS NOTED TO BE DISENGAGED FROM THE TIBIAL TRAY AND COME OUT EASILY. THE FEMORAL COMPONENT WAS FOUND TO BE LOOSE AND WAS REMOVED. THE TIBIAL COMPONENT WAS FOUND TO BE WELL FIXED. THE TIBIAL COMPONENT WAS REMOVED. NEW DEVICES IMPLANTED. DRESSINGS AND COMPRESSION WRAP WERE APPLIED. THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    ON (B)(6) 2012, A (B)(6) Y/O, MALE PATIENT WITH A BMI OF 22.3, UNDERWENT IMPLANTATION OF A INSERT TIBIA LOGIC PSC SZ3 9MM. ON (B)(6) 2019, APPROXIMATELY 95 MONTHS POST IMPLANT, THE PATIENT UNDERWENT REVISION DUE TO INSTABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845170 INSERT TIBIA LOGIC PSC SZ3 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED JWH EXACTECH, INC. 02-012-35-5013 UNKNOWN 10885862173553

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Disability| R