BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP DM CEMENTLESS SHELL Ø 54

    MDR report key: 5267516 · Received December 4, 2015

    Report

    Report Number
    3005180920-2015-00306
    Event Type
    Injury
    Date Received
    December 4, 2015
    Date of Event
    November 5, 2015
    Report Date
    January 5, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    PMA / PMN Number
    K083116
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2015 THE MEDICAL AFFAIRS DIRECTOR MADE THE FOLLOWING ANALYSIS: MIGRATION OF DOUBLE MOBILITY CUP. THERE ARE NO AVAILABLE XRAYS TO SHOW PRIMARY IMPLANTATION OR PREOPERATIVE STATUS. THE CUP TILTED AND PROTRUDED, AND THE EXPLANT SHOWS NO INGROWTH, AS WAS TO BE EXPECTED. WITH THE AVAILABLE INFORMATION, I CANNOT DRAW A CONCLUSION ON THIS EVENT NOR CAN I ESTABLISH A PLAUSIBLE ROOT CAUSE FOR MIGRATION. BATCH REVIEW PERFORMED ON (B)(4) 2015: LOT 040721: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19 OCTOBER 2004. EXPIRATION DATE: 2009-09-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ON (B)(4) 2015 A FINAL REPORT WAS PREPARED WITH THE INFORMATION HERE ABOVE.

    Additional Manufacturer Narrative · 1

    ON 07 DECEMBER 2015 THE FINAL REPORT WAS APPROVED. ON 10 DECEMBER 2015 IT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Description of Event or Problem · 1

    REVISION BECAUSE OF CUP SINKING. IMPLANT NOT AVAILABLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797653 VERSAFITCUP DM CEMENTLESS SHELL Ø 54 ACETABULAR CEMENTLESS SHELL MEH MEDACTA INTERNATIONAL SA 040721

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention