BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMIS CUP IMPACTOR-M8

    MDR report key: 6445920 · Received March 30, 2017

    Report

    Report Number
    3005180920-2017-00138
    Event Type
    Malfunction
    Date Received
    March 30, 2017
    Date of Event
    February 28, 2017
    Report Date
    March 30, 2017
    Manufacturer
    HPF S.P.A.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 14 MARCH 2017 THE MANUFACTURER OF THE INSTRUMENT PROVIDED A DOCUMENT REVIEW FOR THE PRODUCT INVOLVED IN THIS COMPLAINT REPORTING AS FOLLOWS: BATCH RELEASED ON DATE: 19 JANUARY 2017. N. OF PIECES RELEASED: (B)(4). COMMENTS: ALL THE STEPS, ACCORDING TO OUR ROUTING SHEET AND RELATIVE DRAWINGS, HAVE BEEN PERFORMED CORRECTLY AS WELL AS THE DIMENSIONAL AND FUNCTIONAL CONTROLS. WE HAVE NOT RECEIVED OTHER COMPLAINTS FOR THIS BATCH. CONCLUSIONS: THERE AREN'T NON CONFORMITY ELEMENTS IN THE DOCUMENT REVIEW. BATCH REVIEW OF THE IMPLANT INVOLVED IN THIS REPORT, PERFORMED ON 27 MARCH 2017. MPACT ACETABULAR SHELL Ø50 TWO-HOLES, CODE 01.32.150DH. LOT. 165896 (K132879) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11 NOVEMBER 2016. EXPIRATION DATE: 2021-11-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ON 30 MARCH 2017 THE (B)(4) R&D PROJECT MANAGER PERFORMED A VISUAL INSPECTION OF THE PRODUCT INVOLVED IN THIS COMPLAINT REPORTING AS FOLLOWS: AS RESULTS OF THIS INSPECTION IS IT CLEAR THAT THE ROTATION OF THE CARDAN PARTS IS BLOCKED. A DEFORMATION OF THE CARDAN JOINT CLOSE TO THE THREADED CONNECTION IS VISIBLE: IN PARTICULAR IT SEEMS THAT THE PIN WHICH ASSEMBLE THE CARDAN CONNECTION HAS BEEN DEFORMED DURING THE USAGE. MAYBE AN HIGHT TORSION APPLIED TO THE HANDLE TO DISENGAGE FROM THE IMPLANT CUP SHOULD BE THE ROOT CAUSE.

    Description of Event or Problem · 1

    CUP INSERTER BROKE UPON IMPACTION. THE INSERTER WOULD NOT DISENGAGE FROM THE CUP. THE SURGEON HAD TO REMOVE THE CUP AND USE A STRAIGHT INSERT TO COMPLETE THE SURGERY. THERE WAS APPROXIMATELY A 40 MINUTE DELAY IN SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY. INSTRUMENT IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227374 AMIS CUP IMPACTOR-M8 SURGICAL INSTRUMENT FOR HIP LXH HPF S.P.A. 17H0690

    Patients

    Seq Age Sex Outcome Treatment
    1 Other