BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXACTECH

    MDR report key: 14439527 · Received May 19, 2022

    Report

    Report Number
    1038671-2022-00574
    Event Type
    Injury
    Date Received
    May 19, 2022
    Date of Event
    March 5, 2019
    Report Date
    May 18, 2022
    Manufacturer
    EXACTECH, INC.
    Product Code
    LXH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS A RESULT OF AN FDA INSPECTION CONDUCTED IN JAN 2020, EXACTECH, FEI (B)(4), HAS COMMITTED TO REMEDIATING 3 YEARS OF COMPLAINTS (2017-2020). THIS MDR IS BEING SUBMITTED AS PART OF THAT REMEDIATION. DEVICE EVALUATED BY MFR: NOT RETURNED, ENGINEERING EVALUATION CONDUCTED. DESIGN-RELATED ISSUES: THE DESIGN OF THIS TRULIANT FEMORAL TRIAL HAS BEEN IN THE FIELD SINCE 2017. EXACTECH IS NOT AWARE OF ANY OTHER COMPLAINT REPORTS INVOLVING A BROKEN FEMORAL TRIAL SINCE 2017. (B)(4).MFG-RELATED ISSUES: EXACTECH IS NOT AWARE OF RECEIVING ANY OTHER COMPLAINT REPORTS INVOLVING A PART FROM THIS MANUFACTURING LOT OF (B)(4) PIECES, WHICH HAVE BEEN IN THE FIELD SINCE 2018. THEREFORE, THIS DOES NOT APPEAR TO BE MANUFACTURING RELATED. A REVIEW OF THE RISK MANAGEMENT REPORT (RMR) WAS CONDUCTED TO ENSURE THE RISK WAS INCLUDED AND THE OCCURRENCE IS BELOW THE THRESHOLD. THE RMR FOR THIS TRULIANT FEMORAL TRIAL, 750-2011-032-RMR-INSTRUMENTS REV E, WAS REVIEWED. THE RISK IS CAPTURED. CORRECTIVE ACTIONS ARE NOT REQUIRED BECAUSE THE OCCURRENCE RATE IS ¿VERY LOW¿, AND THE RISK IS CAPTURED IN THE RMR. THE BROKEN INSTRUMENT REPORTED WAS LIKELY THE RESULT OF APPLYING EXCESS FORCE TO THE FEMORAL TRIAL DURING IMPACTION. HOWEVER, THIS CANNOT BE CONFIRMED BECAUSE THE COMPONENT WAS NOT RETURNED FOR EVALUATION. IFU 700-096-181: INSTRUMENT INSPECTION. VISUALLY INSPECT THE INSTRUMENTS FOR DAMAGE SUCH AS FRACTURES; CRACKS; GOUGES; DEFORMATION; BURRS; DISCOLORATION, CORROSION, OR RUST; EXCESSIVE COMPONENT WEAR; NICKS ON CUTTING SURFACES, MISSING OR LOOSE COMPONENTS; BLOCKAGES IN CANNULAE, CLEANING HOLES OR OTHER CAVITIES THAT CANNOT BE REMOVED VIA STANDARD CLEANING; WORN OR DIFFICULT TO READ MARKINGS/ENGRAVINGS; OR OTHER APPARENT DAMAGE. CHECK THE FUNCTION OF MECHANISMS BY ACTUATING ANY LEVERS, KNOBS, SWITCHES, CONNECTORS, SLIDING FEATURES, HINGES, OR OTHER MECHANICAL INTERFACE FEATURES. ENSURE SMOOTH OPERATION OF THESE FEATURES OVER THEIR FUNCTIONAL RANGE OF MOTION. IF DAMAGE, WEAR, OR NON-FUNCTIONING/POORLY FUNCTIONING MECHANISMS ARE FOUND, DO NOT USE THE INSTRUMENT, AND CONTACT THE SALES REPRESENTATIVE OR CUSTOMER SERVICE FOR DISPOSITION. IFU STATES: THE SURGEON SHALL BECOME THOROUGHLY FAMILIAR WITH THE TECHNIQUE OF IMPLANTATION OF THE PROSTHESES BY: APPROPRIATE READING OF THE LITERATURE, AND TRAINING IN THE OPERATIVE SKILLS AND TECHNIQUES REQUIRED FOR SURGERY, AND REVIEWING INFORMATION REGARDING USE OF INSTRUMENTATION. IT IS A CLINICAL STANDARD OF PRACTICE IN THE OPERATING ROOM THAT ALL INSTRUMENTS SHOULD BE VISUALLY AND FUNCTIONALLY INSPECTED BEFORE USE, THESE GUIDELINES ARE FROM STANDARD ASSOCIATION OF PERI-OPERATIVE REGISTERED NURSES (AORN) GUIDELINES. SURGEONS ARE TO BE FAMILIAR AND KNOWLEDGEABLE WITH ALL INSTRUMENTATION, DEVICES AND PROFICIENT WITH SURGICAL TECHNIQUES. THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. BASED ON A REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO REASONABLY SUGGEST THE REPORTED INSTRUMENT MALFUNCTION IS RELATED TO ANY MANUFACTURING ISSUES OR DESIGN ISSUES, NOR DID IT LEAD TO ANY REPORTED PATIENT IMPACT.

    Description of Event or Problem · 0

    IT WAS REPORTED FROM THE US THAT DURING AN ORTHOPEDIC SURGERY THE SURGEON EXPERIENCED AN ISSUE WITH THE FEMORAL TRIAL. THE FEMORAL TRIAL WITH THE TRIAL STEM WERE IMPACTED ONTO THE FEMUR AT THAT POINT BOTH TRIAL CONDYLES BROKE OFF. ALL PIECES WERE ACCOUNTED FOR. ACCORDING TO THE REPRESENTATIVE, AT THIS TIME THE SURGEON HAD ALREADY CONFIRMED THE SIZE AND INSERT THICKNESS AND THE SURGEON COMPLETED THE SURGERY WITHOUT DELAY OR ANY COMPROMISE TO THE PATIENT. IMAGES WERE PROVIDED. THE DEVICE WAS NOT RECEIVED FOR ANALYSIS. ATTEMPTS WERE MADE TO REQUEST ADDITIONAL INFORMATION FROM THE REP, BUT NO RESPONSES WERE RECEIVED. NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1976152 EXACTECH TRULIANT CC FEM TRIAL SIZE 3 LXH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Unknown Required Intervention