BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP DM ACETABULAR SHELL Ø 50

    MDR report key: 5172850 · Received October 24, 2015

    Report

    Report Number
    3005180920-2015-00250
    Event Type
    Injury
    Date Received
    October 24, 2015
    Date of Event
    September 22, 2015
    Report Date
    January 20, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    PMA / PMN Number
    K083116
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 23 DEC 2015 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INITIAL REPORT. ON 28 DEC 2015 THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 23 OCTOBER 2015: LOT 083735: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25 FEBRUARY 2009. EXPIRATION DATE: 2014-01-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED ISSUE. OTHER EXPLANTED COMPONENTS: VERSAFITCUP DOUBLE MOBILITY LINER DIAM 50/28 CODE 01.26.2850M LOT. 090084 (K083116): LOT 090084: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06 APRIL 2009. EXPIRATION DATE: 2014-02-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED ISSUE. MECTACER BIOLOX FORTE CERAMIC BALL HEAD 12/14 Ø 28 SIZE M 0 CODE 38.39.7175.255.00 LOT. 092490 (K073337): LOT 092490: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20 OCTOBER 2009. EXPIRATION DATE: 2014-09-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED ISSUE. QUADRA H CEMENTLESS, HA COATED STD STEM # 2, SHORT NECK CODE 01.12.22SN LOT. 090113 (K082792): LOT 090113: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25 FEBRUARY 2009. EXPIRATION DATE: 2014-01-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED ISSUE.

    Description of Event or Problem · 1

    THE PATIENT HAD TO HAVE THEIR THA REVISED DUE TO OSTEOLYSIS. NO X-RAYS ARE AVAILABLE. THE EXPLANTS WILL NOT BE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703426 VERSAFITCUP DM ACETABULAR SHELL Ø 50 ACETABULAR CEMENTLESS SHELL MEH MEDACTA INTERNATIONAL SA 083735

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention