BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT STD, SZ 4, 11MM

    MDR report key: 13006131 · Received December 14, 2021

    Report

    Report Number
    1038671-2021-00701
    Event Type
    Injury
    Date Received
    December 14, 2021
    Date of Event
    November 22, 2021
    Report Date
    May 25, 2022
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862174451
    PMA / PMN Number
    K111400
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: LOGIC CR FEMORAL CEM, LEFT, SZ 4 (CAT# 02-010-03-0240 / SERIAL# (B)(4)). LGC TIBIAL FIT TRAY CEM SZ 4F / 5T (CAT# 02-012-45-4050 / SERIAL# (B)(4)). THREE PEG PATELLA 38MM (CAT# 200-02-38 / CAT# 4243255). ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    THE REVISION REPORTED WAS LIKELY THE RESULT OF A COMBINATION OF THIRD BODY WEAR AND PROGRESSIVE INSTABILITY, WHICH LED TO WEAR AND DELAMINATION OF THE POLYETHYLENE INSERT.

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: LOGIC CR FEMORAL CEM, LEFT, SZ 4 (CAT# 02-010-03-0240 / SERIAL# (B)(4)). LGC TIBIAL FIT TRAY CEM SZ 4F / 5T (CAT# 02-012-45-4050 / SERIAL# (B)(4)). THREE PEG PATELLA 38MM (CAT# 200-02-38 / CAT# 4243255). ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 5 YRS POSTOP THE INITIAL L TKA THIS (B)(6) MALE PATIENT PRESENTING WITH COMPLAINING OF SWELLING OF HIS LEFT KNEE FOR THE PAST 2 YEARS FOLLOWED BY INSTABILITY AND WAS SCHEDULED FOR A REVISION DUE TO INCREASE WEAR ON LEFT TIBIAL SURFACE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES ARE EXPECTED TO BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 5 YRS POSTOP THE INITIAL L TKA THIS (B)(6) MALE PATIENT PRESENTING WITH COMPLAINING OF SWELLING OF HIS LEFT KNEE FOR THE PAST 2 YEARS FOLLOWED BY INSTABILITY AND WAS SCHEDULED FOR A REVISION DUE TO INCREASE WEAR ON LEFT TIBIAL SURFACE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES ARE EXPECTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1894997 LOGIC CR TIB INSERT STD, SZ 4, 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. LOGIC CR TIB INSERT STD, SZ 4, 11MM UNK 10885862174451

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention