BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA PS MOD INSRT SZ 3.5 11MM

    MDR report key: 12281194 · Received August 5, 2021

    Report

    Report Number
    1038671-2021-00370
    Event Type
    Injury
    Date Received
    August 5, 2021
    Date of Event
    July 13, 2021
    Report Date
    November 6, 2021
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001856
    PMA / PMN Number
    K093360
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER REVIEW OF ADDITIONAL INFORMATION RECEIVED THE FOLLOWING SECTIONS G3, G7, H2, H3 AND H6 HAVE BEEN UPDATED ACCORDINGLY. (H3) THE EVALUATION NOTED THAT REVISION REPORTED WAS LIKELY THE RESULT OF THE TIBIAL INSERT NOT BEING FULLY ENGAGED IN THE TIBIAL TRAY, POSSIBLY DUE TO INCOMPLETE SEATING DURING IMPLANTATION, AND A TIGHT MCL, AS STATED BY THE SURGEON, WHICH LED TO THE REPORTED PROSTHESIS WEAR AND DAMAGE. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICE WAS NOT AVAILABLE FOR EVALUATION, AND X-RAY IMAGES WERE NOT PROVIDED. THE MOST PROBABLE ROOT CAUSE ASSOCIATED WITH THE REPORTED EVENT OF " PROSTHESIS WEAR" IS ASSOCIATED WITH MATERIAL DAMAGE TO A SURFACE, USUALLY INVOLVING PROGRESSIVE LOSS OR DISPLACEMENT OF MATERIAL, DUE TO RELATIVE MOTION BETWEEN THAT SURFACE AND A CONTACTING SUBSTANCE OR SUBSTANCES.

    Additional Manufacturer Narrative · 1

    CONCOMITANT DEVICES: 02-010-01-0335, 2345060 - LOGIC FEMORAL PS CEM RIGHT SZ 3.5. 02-012-45-3535, 2667106 - LGC TIBIAL FIT TRAY CEM SZ 3.5F / 3.5T. 200-02-35, 2731562 - THREE PEG PATELLA 35MM. 201-78-97, 2747582 - 2 PK, SCHANZ PIN, 3MM X 145MM. 203-96-42, 35156 - 11-4132 STRYKER SYS 6 90X13/21X1.19. A10007, 04 0230 13 004 - GPS KNEE IMPLANT KIT. ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    AS REPORTED, SURGEON DID A POLY EXCHANGE AND NOTED SIGNIFICANT POLY WEAR AND DAMAGE. SURGEON BELIEVES THE ORIGINAL POLY WAS NOT FULLY ENGAGED IN THE TIBIA AND THAT THE MCL WAS ALSO TIGHT. HE RELEASED MCL AND THE KNEE WAS BALANCED WELL WITH A NEW 11 PS INSERT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION. NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1179199 LOGIC TIBIA PS MOD INSRT SZ 3.5 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 3.5 11MM UNK 10885862001856

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Disability| R