BEUDAMED
    FDA Adverse Event Injury Summary report: N

    METHA NECK 12/14 135°/0°

    MDR report key: 5650706 · Received May 12, 2016

    Report

    Report Number
    3005673311-2016-00080
    Event Type
    Injury
    Date Received
    May 12, 2016
    Date of Event
    April 6, 2016
    Report Date
    May 24, 2016
    Manufacturer
    AESCULAP IMPLANT SYSTEMS
    Product Code
    LWJ
    PMA / PMN Number
    K071916
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT ARRIVED IN A CLEAN BUT NOT DECONTAMINATED CONDITION. TEST-AND ANALYSIS EQUIPMENT USED: MICROSCOPE "(B)(4)- VHX 600 D." DIGITAL-CAMERA "(B)(4) DMC TZ8. RF GENERATOR "GN 200", SNR. (B)(4). VISUAL INSPECTION OF THE JAW WAS COMPLETED. IN ADDITION TO THE DAMAGED SHRINK HOSE AT THE DISTAL END, THERE WAS DAMAGE OF THE SHRINK HOSE ON THE SHAFT NOTED. MECHANICAL FUNCTION OF THE DEVICE WAS TESTED. THE CLAMPING AND THE CUTTING FUNCTION WORKED WELL. IN THE NEXT STEP THE DEVICE WAS CONNECTED WITH AN RF- GENERATOR "GN 200", SERIAL NO.(B)(4) AND THE ELECTRICAL FUNCTIONS WERE CHECKED. RESULTS ARE: TEST STEP: GENERATOR- ANNOUNCEMENT: RESULT: ACTIVATION WITH OPEN JAW, "REGRASP OPEN", O.K. ACTIVATION WITH CLOSED JAW, "REGRASP OPEN", O.K. ACTIVATION WITH WET TISSUE, "SEALING", O.K. ACTIVATION WITH TIN-FOIL IN JAW, "REGRASP SHORT", O.K. THE ELECTRICAL FUNCTIONS ARE WITHOUT DEVIATION TO THE SPECIFICATION. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND FOUND TO BE ACCORDING TO SPECIFICATION VALID DURING THE TIME OF PRODUCTION. IT APPEARS THAT THE SURGEON FORGOT TO REPOSITION THE TIP TO THE STRAIGHT POSITION BEFORE REMOVING THE INSTRUMENT FROM THE TROCAR. THIS, MAYBE IN CONJUNCTION WITH A SHARP EDGED TROCAR, IS THE ONLY EXPLANATION FOR DAMAGE PRESENT ON THE DEVICE. A SHARP EDGED TROCAR IS THE ONLY EXPLANATION FOR THE DAMAGE ON THE SHAFT. THE DESIGN WAS EVALUATED DURING DEVELOPMENT. THIS ERROR PATTERN IS NOT DOCUMENTED. IT IS MENTIONED IN THE IFU, THAT A DAMAGE CAN OCCUR BY REMOVING THE INSTRUMENT FROM THE TROCAR WITH DISTALLY ARTICULATED JAW PART. IT CAN ALSO OCCUR IF THE INSTRUMENT IS USED WITH A SHARP EDGED TROCAR. CORRECTIVE / PREVENTIVE ACTION HAS BEEN INITIATED TO INCLUDE THIS FAILURE MODE IN THE RISK ANALYSIS.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). REVISION SURGERY DUE TO METALLOSIS. ORIGINAL SURGERY DATE: (B)(6) 2011 USING A HYBRID METHA IMPLANT. ADDITIONAL COMPONENTS (NON-AESCULAP) INCLUDE: CERAMIC HEAD BY FINSBURY ORTHOPAEDICS LTD ((B)(4)) REF. 167-140F BATCH (B)(4). ACETABULAR CUP BY FINSBURY ORTHOPAEDICS LTD ((B)(4)) REF.168-112F BATCH (B)(4). TAPER FINSBURY ORTHOPAEDICS LTD ((B)(4)) REF. 167-061F BATCH (B)(4). SECOND MED WATCH REPORT FOR THIS INCIDENT, (B)(4) / METHA SHORT HIP STEM, HAS BEEN REPORTED. MED WATCH REPORT 3005673311-2016-00079.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306284 METHA NECK 12/14 135°/0° HIP ENDOPROSTHESIS LWJ AESCULAP IMPLANT SYSTEMS NC088K 51698063

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other