BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUP: MPACT 3DMETAL 01.38.052DH ACETABULAR SHELL Ø52 TWO-HOLE

    MDR report key: 8361559 · Received February 22, 2019

    Report

    Report Number
    3005180920-2019-00093
    Event Type
    Malfunction
    Date Received
    February 22, 2019
    Date of Event
    January 25, 2019
    Report Date
    February 22, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030812590
    PMA / PMN Number
    K171966
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 22 FEBRUARY 2019: LOT 153941: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04 APRIL 2016. EXPIRATION DATE: 2021-01-02. 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. ADDITIONAL DEVICE INVOLVED IN THE EVENT, CE MARKED BY THE SUPPLIER: AMIS 01.15.10.0538 AMIS CUP IMPACTOR-M8 INCIPIO LOT. 17J3319. THE MANUFACTURER HAS BEEN INFORMED ABOUT THE EVENT. PRELIMINARY INVESTIGATION PERFORMED BY R&D PROJECT MANAGER ON THE BASIS OF THE RECEIVED PICTURE: LOOKING AT THE IMAGE ATTACHED TO THE COMPLAINT IT IS EVALUABLE THAT THE CUP IS BLOCKED ON THE CUP IMPACTOR, THE LEVER OF THE CUP IMPACTOR IS CLOSE AND IT SEEM THAT THE CARDAN SCREWDRIVER IS OUT OF ITS NEUTRAL POSITION. MORE DETAILS WILL BE ADDED DURING THE VISUAL INSPECTION. IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE. THE INSTRUMENT IS CE MARKED BY SUPPLIER.

    Description of Event or Problem · 1

    DURING THE PRIMARY HIP SURGERY AND AFTER IMPACTING THE 52MM CUP, IT WAS DISCOVERED THAT THE IMPACTOR HANDLE WOULD NOT DISENGAGE FROM THE CUP. THE SURGEON REMOVED THE ORIGINAL CUP AND IMPLANTED A DIFFERENT 52MM CUP USING A DIFFERENT IMPACTOR HANDLE WITH NO ISSUES. THERE WAS A 5 MINUTE DELAY IN THE CASE AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157842 CUP: MPACT 3DMETAL 01.38.052DH ACETABULAR SHELL Ø52 TWO-HOLE CEMENTLESS ACETABULAR SHELL LPH MEDACTA INTERNATIONAL SA 153941 07630030812590

    Patients

    Seq Age Sex Outcome Treatment
    1 Other