BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA PS MOD INSRT SZ 3 11MM

    MDR report key: 13173078 · Received January 5, 2022

    Report

    Report Number
    1038671-2022-00010
    Event Type
    Injury
    Date Received
    January 5, 2022
    Date of Event
    March 19, 2019
    Report Date
    July 25, 2022
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001818
    PMA / PMN Number
    K033883
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: TIBIAL AUGMENT BLOCK 1/2-SZ 3 11MM LLRM (CAT# 204-63-89 / SERIAL# (B)(4)); TIBIAL AUGMENT BLOCK 1/2-SZ 3 11MM RLLM (CAT# 204-63-88 / SERIAL# (B)(4)); THREE PEG PATELLA 32MM (CAT# 200-02-32 / SERIAL# (B)(4)); STEM EXTENSION 80L X12 MM (CAT# 204-32-08 / SERIAL# (B)(4)); CC POSTERIOR FEM AUGMENT SZ 2, 5MM (CAT# 208-07-02 / SERIAL# (B)(4)); CC STEM EXT ADAPTOR 5 DEGREE (CAT# 208-09-05 / SERIAL# (B)(4)); TRAPEZOID TIBIAL TRAY SZ 1F/3T, 2F/3T (CAT# 204-04-23 / SERIAL# (B)(4)); CC FEMORAL SZ 2 (CAT# 208-01-02 / SERIAL# (B)(4)); FLUTED STEM EXTENSION 80L X 14 MM (CAT# 204-34-08 / SERIAL# (B)(4)); CC DISTAL FEM AUGMENT SZ 2, 5MM (CAT# 208-05-02 / SERIAL# (B)(4)); CC DISTAL FEM AUGMENT SZ 2, 5MM (CAT# 208-05-02 / SERIAL# (B)(4)). ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    (H3) AS REPORTED, APPROXIMATELY THREE YEARS POST TKA, PATIENT HAD A REVISION FOR AN UNKNOWN REASON. CC INSERT WITH > 5-YEARS AT IMPLANTATION BUT OUT OF SCOPE FOR THE PE LINER ISSUE. NO ADDITIONAL INFORMATION AVAILABLE. UPON REVIEW, THERE IS NO ALLEGATION AGAINST THE DEVICE AS THE REASON FOR REVISION WAS NOT REPORTED. THE MOST LIKELY CAUSE OF THE REPORTED EVENT IS PATIENT CONDITIONS.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY THREE YEARS POST TKA, PATIENT HAD A REVISION FOR AN UNKNOWN REASON. CC INSERT WITH > 5-YEARS AT IMPLANTATION BUT OUT OF SCOPE FOR THE PE LINER ISSUE. NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616549 LOGIC TIBIA PS MOD INSRT SZ 3 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 3 11MM UNK 10885862001818

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention