BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMIS CUP IMPACTOR TERMINAL-M10

    MDR report key: 8969653 · Received September 6, 2019

    Report

    Report Number
    3005180920-2019-00738
    Event Type
    Malfunction
    Date Received
    September 6, 2019
    Date of Event
    August 7, 2019
    Report Date
    September 6, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LXH
    UDI-DI
    07630040736015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 09-AUGUST-2019 LOT 1755175: (B)(4). NO ANOMALIES FOUND RELATED TO THE PROBLEM TO DATE, NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED. VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER. DURING THE ANALYSIS IT IS EVALUATED THAT THE BALINIT-C COATING OF THE TERMINAL IS REMOVED FROM THE AREA IN CONNECTION WITH THE CUP, IN ADDITION SOME SCRATCHES ARE PRESENT OF THE WHOLE BODY AND FINALLY THE THREADED PART IS DAMAGED. DUE TO THE DAMAGES INDICATED ABOVE THE TERMINAL WAS BLOCKED IN THE CUP AS ROOT CAUSE. ADDITIONAL DEVICE INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 09-AUGUST-2019 LOT 1810201: (B)(4), EXPIRATION DATE: 2024-03-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    AFTER THE SURGEON IMPACTED THE CUP, IT WAS NOT POSSIBLE TO DISCONNECT THE TERMINAL CUP IMPACTOR. HE HAD TO EXPLANT THE CUP AND USE A NEW ONE WITH THE STRAIGHT CUP IMPACTOR. THERE WAS A 5 MINUTES DELAY

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764959 AMIS CUP IMPACTOR TERMINAL-M10 SURGICAL INSTRUMENT FOR HIP SURGERY LXH MEDACTA INTERNATIONAL SA 1755175 07630040736015

    Patients

    Seq Age Sex Outcome Treatment
    1 Other