BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA IMPLANT PSC INSERT, SZ 3, 9MM

    MDR report key: 12073197 · Received June 27, 2021

    Report

    Report Number
    1038671-2021-00314
    Event Type
    Injury
    Date Received
    June 27, 2021
    Date of Event
    May 27, 2021
    Report Date
    March 7, 2022
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862173553
    PMA / PMN Number
    K110547
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (H3) THE PENDING REVISION REPORTED IS MOST LIKELY DUE TO A COMBINATION OF PROSTHESIS WEAR AND KNEE INSTABILITY. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION AND NO REVISION INFORMATION WAS AVAILABLE. 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. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENT AND THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 1038671-2021-00313 AND 1038671-2021-00314.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: THREE PEG PATELLA 32MM (CAT# 200-02-32 / SERIAL# (B)(4)). THREE PEG PATELLA 32MM (CAT# 200-02-32 / SERIAL# (B)(4)). LOGIC FEMORAL PS CEM LEFT SZ 3 (CAT# 02-010-01-0230 / SERIAL# (B)(4)). LGC TIBIAL FIT TRAY CEM SZ 3F / 3T (CAT# 02-012-45-3030 / SERIAL # (B)(4)). LOGIC FEMORAL PS CEM RIGHT SZ 4 (CAT# 02-010-01-0340 / SERIAL# (B)(4)). LGC TIBIAL FIT TRAY CEM SZ 4F / 3T (CAT# 02-012-45-4030 / SERIAL# (B)(4)). ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENT AND THE ASSOCIATED MANUFACTURER REPORT NUMBER IS 1038671-2021-00313.

    Description of Event or Problem · 1

    AS REPORTED, THE SURGEON REPORTED TO THE CLINICAL STUDY REGARDING A (B)(6) Y/O MALE PATIENT WITH BILATERAL OPTETRAK LOGIC KNEES THAT APPEARS TO BE EXPERIENCING WEAR OF THE L TIBIAL INSERT ABOUT 4 YEARS AFTER INITIAL SURGERY. SURGEON CURRENT PLAN IS TO CONDUCT STAGED BILATERAL REVISIONS; HOWEVER, THE PATIENT DOES NOT WANT TO COME INTO THE OFFICE BECAUSE OF COVID. REVISION HAS NOT BEEN COMPLETED AND DEVICES REMAIN IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    969731 LOGIC TIBIA IMPLANT PSC INSERT, SZ 3, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED JWH EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 3, 9MM UNK 10885862173553

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Disability| R