BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP DM CEMENTLESS SHELL Ø 48

    MDR report key: 5306664 · Received December 17, 2015

    Report

    Report Number
    3005180920-2015-00333
    Event Type
    Injury
    Date Received
    December 17, 2015
    Date of Event
    November 17, 2015
    Report Date
    March 14, 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 (B)(6) 2015 WE WERE INFORMED THAT THE REVISION WAS DUE TO INFECTION BUT THE PATHOLOGY RESULTS WERE NOT AVAILABLE. BATCH REVIEW PERFORMED ON 15 DECEMBER 2015: VERSAFITCUP DM ACETABULAR SHELL Ø 48 CODE 01.26.48MB LOT. 135595: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26 FEB 2014. EXPIRATION DATE: 2019-01-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED ISSUE. DOUBLE MOBILITY HC PE LINER CODE 01.26.2848MHC LOT. 135628 (K092265): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07 FEB 2014. EXPIRATION DATE: 2018-12-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE S CODE 01.29.201 LOT. 135713 (K112115): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05 FEB 2014. EXPIRATION DATE: 2018-12-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED ISSUE. AMISTEM H CEMENTLESS STEM STD #1 CODE 01.18.131 LOT. 120446 (K093944): (B)(4) ITEM MANUFACTURED AND RELEASED ON 03 APR 2012. EXPIRATION DATE: 2017-02-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED ISSUE.

    Additional Manufacturer Narrative · 1

    ON 15 FEBRUARY 2016 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INTIAL REPORT. ON 21 FEBRUARY 2016 THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Description of Event or Problem · 1

    THE PATIENT CAME IN WITH PAIN AND SWELLING IN HER HIP. THE SURGEON REMOVED ALL HIP IMPLANTS AND PUT IN ANTIBIOTIC SPACERS. THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE ARE NO X-RAYS. THE EXPLANTS WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832665 VERSAFITCUP DM CEMENTLESS SHELL Ø 48 ACETABULAR CEMENTLESS SHELL MEH MEDACTA INTERNATIONAL SA 135595

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention