BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP DM HC LINER Ø 48

    MDR report key: 5114132 · Received September 30, 2015

    Report

    Report Number
    3005180920-2015-00213
    Event Type
    Injury
    Date Received
    September 30, 2015
    Date of Event
    August 31, 2015
    Report Date
    December 22, 2015
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    PMA / PMN Number
    K092265
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 30 SEPTEMBER 2015: LOT 152098: (B)(4) LINERS MANUFACTURED AND RELEASED ON 07 JULY 2015. EXPIRATION DATE: 2020-05-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED ISSUE. MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE L +3.5 REF. 01.29.203 LOT. 148056 (K112115): LOT 148056: (B)(4) HEADS MANUFACTURED AND RELEASED ON 25 MARCH 2015. EXPIRATION DATE: 2020-01-31. 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. AMISTEM H STD STEM #3 REF. 01.18.133 LOT. 151437 (K093944): LOT 151437: (B)(4) STEMS MANUFACTURED AND RELEASED ON 23 JUNE 2015. EXPIRATION DATE: 2020-05-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED ISSUE. VERSAFITCUP DM ACETABULAR SHELL Ø 48 REF. 01.26.48MB LOT. 152014 (K083116): LOT 152014: (B)(4) SHELLS MANUFACTURED AND RELEASED ON 10 AUGUST 2015. EXPIRATION DATE: 2020-06-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED ISSUE. ON 30 SEP 2015 THE MEDICAL AFFAIRS DIRECTOR STATED THAT: ACCORDING TO REPORT, THE ROOT CAUSE FOR THIS REVISION IS INFECTION.

    Additional Manufacturer Narrative · 1

    ON 27 NOV 2015 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INITIAL REPORT. ON THE SAME DAY IT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Description of Event or Problem · 1

    THE PATIENT WAS COMPLAINING OF PAIN. ON (B)(6) 2015 THE SURGEON THOUGHT IT COULD BE AN INFECTION SO HE PREFORMED AN I & D AND REPLACED THE HEAD AND LINER. AFTER THE PRELIMINARY PATHOLOGY RESULTS CAME BACK, THE SURGEON DECIDED TO REMOVE ALL COMPONENTS AND INSERT AN ANTIBIOTIC SPACER ON (B)(6) 2015. UPDATE RECEIVED ON SEP, 9TH 2015 ABOUT THE PATHOGEN: "ENTEROBACTER CLOACAE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646461 VERSAFITCUP DM HC LINER Ø 48 DOUBLE MOBILITY PE LINER MEH MEDACTA INTERNATIONAL SA 152098

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention