BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT SLOPE+, SZ 4, 9MM

    MDR report key: 16459132 · Received March 1, 2023

    Report

    Report Number
    1038671-2023-00290
    Event Type
    Injury
    Date Received
    March 1, 2023
    Date of Event
    August 31, 2022
    Report Date
    June 5, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862174482
    PMA / PMN Number
    K111400
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: 200-02-35, 4271375 - THREE PEG PATELLA 35MM. 02-010-03-0340, 4741529 - LOGIC CR FEMORAL CEM, RIGHT, SZ 4. 02-012-45-4040, 4834475 - LGC TIBIAL FIT TRAY CEM SZ 4F / 4T.

    Additional Manufacturer Narrative · 0

    ADDITIONAL MANUFACTURER NARRATIVE- B5 ADDITIONAL INFORMATION, H6. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

    Additional Manufacturer Narrative · 0

    THE REVISION REPORTED MAY HAVE BEEN THE RESULT OF MALALIGNMENT BETWEEN THE FEMORAL AND TIBIAL COMPONENTS, THIRD BODY WEAR, PATIENT-RELATED CONDITIONS, INSTABILITY, OR ANY COMBINATION OF THESE POSSIBILITIES, WHICH LED TO WEAR OF THE POLYETHYLENE INSERT. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION AND IMAGES OF THE EXPLANTED DEVICE AND PRE-REVISION RADIOGRAPHS WERE NOT PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE LEGAL DEPARTMENT THAT, THE POLYETHYLENE COMPONENTS WITHIN THE PATIENT KNEE PROSTHESES PREMATURELY DEGRADED OVER TIME CAUSING AN INFLAMMATORY RESPONSE RESULTING IN OSTEOLYSIS. THE PATIENT WILL UNDERGO A REVISION SURGERY DUE TO SEVERE PAIN, SWELLING, AND INSTABILITY IN THE KNEE AND LEG. THIS DEVICE WAS PART OF THE RECALL.

    Description of Event or Problem · 0

    REVISION OPERATIVE REPORT -POSTOPERATIVE DIAGNOSIS: RIGHT TOTAL KNEE WITH POLYETHYLENE FAILURE. PATIENT PRESENTED WITH PAIN AND SWELLING. CONFIRMED EFFUSION. NO LYTIC PROCESS. NEGATIVE FOR INFECTION. REMOVAL OF POLYETHYLENE WITH EVIDENCE OF DISCOLORATION AND PITTING. PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION, NO COMPLICATION THROUGHOUT THE CASE. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1054502 LOGIC CR TIB INSERT SLOPE+, SZ 4, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK UNK 10885862174482

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Required Intervention