BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP ACETABULAR SHELL

    MDR report key: 7160289 · Received January 3, 2018

    Report

    Report Number
    3005180920-2017-00805
    Event Type
    Injury
    Date Received
    January 3, 2018
    Date of Event
    December 6, 2017
    Report Date
    May 17, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030808098
    PMA / PMN Number
    K083116
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 22 DEC 2017 THE MEDICAL AFFAIRS MADE THE FOLLOWING ANALYSIS: LATE INFECTION IN CEMENTLESS THA, 7 MONTHS AFTER PRIMARY OPERATION. INFECTION IS A KNOWN POSSIBLE ADVERSE EVENT FOLLOWING EVERY SURGERY, INCLUDING THA'S. TO DATE, THERE IS NO REASON TO SUSPECT THAT THE CAUSE MAY BE LINKED TO THE IMPLANTED DEVICES. BATCH REVIEWS PERFORMED ON 02 JANUARY 2018: LOT 163140: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15 SEPTEMBER 2016. EXPIRATION DATE: 2021-08-29. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. AMISTEM H HA COATED STD STEM #6 REF. 01.18.136 LOT. 165573 (K093944): LOT 165573: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21 DECEMBER 2016. EXPIRATION DATE: 2021-12-04. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. VERSAFITCUP DM C LINER Ø 52/28 REF. 01.26.2852MHC LOT. 162321 (K092265): LOT 162321: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25 JULY 2016. EXPIRATION DATE: 2021-06-29. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH 2 SIMILAR REPORTED EVENTS. COCR BALL HEAD 12/14 Ø 28 SIZE M REF. 01.25.012 LOT. 164835 (K072857): LOT 164835: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17 OCTOBER 2016. EXPIRATION DATE: 2021-10-04. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    THE SECOND STEP OF THE REVISION WAS COMPLETED ON (B)(6) 2018. THE SURGEON REMOVED THE SPACER AND IMPLANTED PERMANENT PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE INFECTION IS CONFIRMED AS RARE BETA HEMOLYTIC STREPTOCOCCI. THE SURGEON REMOVED ALL MEDACTA HARDWARE AND IMPLANTED A SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3289 VERSAFITCUP ACETABULAR SHELL ACETABULAR CEMENTLESS SHELL MEH MEDACTA INTERNATIONAL SA 163140 07630030808098

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention