BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB FIT TRAY CEM SZ 3F / 3T

    MDR report key: 14632598 · Received June 8, 2022

    Report

    Report Number
    1038671-2022-00653
    Event Type
    Injury
    Date Received
    June 8, 2022
    Date of Event
    January 23, 2020
    Report Date
    December 1, 2022
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862305824
    PMA / PMN Number
    K152170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANTS MEDICAL PRODUCT: FEMORAL COMPONENT (CAT# 02-020-13-3011), TIBIAL INSERT (CAT# 02-022-47-3030), THREE PEG PATELLA 32MM (CAT# 200-02-32), OPTETRAK (4) HOLDING PINS (CAT# 201-78-15). ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT

    Additional Manufacturer Narrative · 0

    H3: AS REPORTED BY THE EXACTECH KNEE REPLACEMENT STUDY, APPROXIMATELY THREE MONTHS POST INITIAL RIGHT TKA, THE 53 Y/O FEMALE OBESE PATIENT COMPLAINS THAT BECAUSE OF POST -OP INFECTIONS AND LOSS OF RANGE OF MOTION. ¿PATIENT DOCUMENTS THAT SHE IS MORE CRIPPLED THAN BEFORE SURGERY.¿ THE EVENT IS STILL ONGOING. PER CLINICAL STUDY CASE REPORT THIS EVENT IS POSSIBLY RELATED TO DEVICES AND TO PROCEDURE. BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN OR MANUFACTURING ISSUES. THE CAUSE OF INFECTION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS.

    Description of Event or Problem · 0

    AS REPORTED BY THE EXACTECH KNEE REPLACEMENT STUDY, APPROXIMATELY THREE MONTHS POST INITIAL TKA, THE (B)(6) FEMALE PATIENT COMPLAINS THAT BECAUSE OF POST -OP INFECTIONS AND LOSS OF RANGE OF MOTION. PATIENT DOCUMENTS THAT SHE IS MORE CRIPPLED THAN BEFORE SURGERY. THE EVEN IS STILL ONGOING. PER CLINICAL STUDY CASE REPORT THIS EVENT IS POSSIBLY RELATED TO DEVICES AND TO PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13688 TRULIANT TIB FIT TRAY CEM SZ 3F / 3T PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. TRULIANT TIB FIT TRAY CEM SZ 3F / 3T UNK 10885862305824

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Required Intervention