BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC FEMORAL PS CEM LEFT SZ 3.5

    MDR report key: 13159906 · Received January 4, 2022

    Report

    Report Number
    1038671-2022-00004
    Event Type
    Injury
    Date Received
    January 4, 2022
    Date of Event
    December 16, 2021
    Report Date
    May 16, 2022
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001153
    PMA / PMN Number
    K033883
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: LOGIC TIBIA PS MOD INSRT SZ 3.5 11MM (CAT# 02-012-35-3511 / SERIAL# (B)(4), LGC TIBIAL FIT TRAY CEM SZ 3.5F / 2.5T (CAT# 02-012-45-3525 / SERIAL# (B)(4), THREE PEG PATELLA 32MM (CAT# 200-02-32 / SERIAL# (B)(4), LOGIC FEMORAL PS CEM RIGHT SZ 3.5 (CAT# 02-010-01-0335 / SERIAL# (B)(4), LOGIC TIBIA PS MOD INSRT SZ 3.5 9MM (CAT# 02-012-35-3509 / SERIAL# (B)(4), LGC TIBIAL FIT TRAY CEM SZ 3.5F / 2.5T (CAT# 02-012-45-3525 / SERIAL# (B)(4), THREE PEG PATELLA 35MM (CAT# 200-02-35 / SERIAL# (B)(4), HOLDING PIN MINI SHARP POINT 4 PK (CAT# 201-78-15 / SERIAL# (B)(4). ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    AFTER FURTHER REVIEW OF ADDITIONAL INFORMATION RECEIVED THE FOLLOWING SECTIONS D9, G3, G6, H2, H3 AND H6 HAVE BEEN UPDATED ACCORDINGLY. (H3) THE REVISION REPORTED WAS LIKELY THE RESULT OF AN INSUFFICIENT BOND BETWEEN THE FEMORAL COMPONENT AND THE BONE AND PATIENT-RELATED CONDITIONS, WHICH LED TO ASEPTIC (NON-INFECTED) FEMORAL LOOSENING. THE MOST PROBABLE ROOT CAUSE ASSOCIATED WITH THE REPORTED EVENT OF "LOOSENING - FEMORAL¿ IS ASSOCIATED WITH WEAKENED INTEGRATION OF THE FEMORAL COMPONENT AT THE BONE-IMPLANT INTERFACE DUE TO LOSS OF FIBROUS AND/OR BONY TISSUE AND LEADING TO COMPROMISED ANCHORAGE OF THE DEVICE. SECTION D10: CONCOMITANT MEDICAL PRODUCTS - THESE DEVICES REMAIN IMPLANTED. LGC TIBIAL FIT TRAY CEM SZ 3.5F / 2.5T (CAT# 02-012-45-3525 / SERIAL# (B)(6)) THREE PEG PATELLA 32MM (CAT# 200-02-32 / SERIAL# (B)(6)) LOGIC FEMORAL PS CEM RIGHT SZ 3.5 (CAT# 02-010-01-0335 / SERIAL# (B)(6)) LOGIC TIBIA PS MOD INSRT SZ 3.5 9MM (CAT# 02-012-35-3509 / SERIAL# (B)(6)) LGC TIBIAL FIT TRAY CEM SZ 3.5F / 2.5T (CAT# 02-012-45-3525 / SERIAL# (B)(6)) THREE PEG PATELLA 35MM (CAT# 200-02-35 / SERIAL# (B)(6)) HOLDING PIN MINI SHARP POINT 4 PK (CAT# 201-78-15 / SERIAL# (B)(6)).

    Description of Event or Problem · 0

    AS REPORTED, A (B)(6) FEMALE PATIENT COMPLAINED OF HAVING PAIN. FEMUR WAS LOOSE. THERE WAS NO BREAKAGE OF DEVICE. THERE WAS NO SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL BE RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1453522 LOGIC FEMORAL PS CEM LEFT SZ 3.5 PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. LOGIC FEMORAL PS CEM LEFT SZ 3.5 UNK 10885862001153

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Required Intervention