BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP ACETABULAR SHELL CC TRIO Ø 50

    MDR report key: 5446935 · Received February 19, 2016

    Report

    Report Number
    3005180920-2016-00050
    Event Type
    Injury
    Date Received
    February 19, 2016
    Date of Event
    January 20, 2016
    Report Date
    May 19, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K103352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 19 APRIL 2016 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INITIAL REPORT. ON 25 APRIL 2016 THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 15 FEBRUARY 2016. LOT 144687: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24 SEPTEMBER 2014. EXPIRATION DATE: 2019-08-31. 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. VERSAFITCUP CC FLAT PE HC LINER Ø 36 / E, CODE 01.26.3644HCT, LOT. 142648 (K120531) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08 JULY 2014. EXPIRATION DATE: 2019-05-31. 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. AMISTEM H, HA COATED STEM SIZE 3 STD, CODE 01.18.133, LOT. 145886 (K093944) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20 OCTOBER 2014. EXPIRATION DATE: 2019-09-30. 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 36 SIZE S , CODE 01.29.208, LOT. 142144 (K112115) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02 OCTOBER 2014. EXPIRATION DATE: 2019-08-31. 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. ON 19 FEBRUARY 2016 THE MEDICAL AFFAIRS DIRECTOR MADE THE FOLLOWING COMMENT WHILE CHECKING THE X-RAY: ACCORDING TO REPORT, THIS SECOND OPERATION WAS ORIGINATED BY AN INFECTION. THERE IS NO REASON TO DOUBT THAT THE INFECTION TOOK PLACE OR TO SUSPECT THAT IT WAS INDUCED BY A DEVICE MALFUNCTION.

    Description of Event or Problem · 1

    THE PATIENT WAS SHOWING SIGNS OF INFECTION. THE SURGEON DECIDED TO REMOVE ALL COMPONENTS AND PUT IN ANTIBIOTIC SPACERS UNTIL THE INFECTION CLEARS. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAY AVAILABLE. THE EXPLANTS ARE NOT AVAILABLE. PATHOGEN: P. ACNES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103583 VERSAFITCUP ACETABULAR SHELL CC TRIO Ø 50 ACETABULAR SHELL LZO MEDACTA INTERNATIONAL SA 144687

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention