BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H, HA COATED STEM SIZE 6 STD

    MDR report key: 5991610 · Received September 30, 2016

    Report

    Report Number
    3005180920-2016-00504
    Event Type
    Injury
    Date Received
    September 30, 2016
    Date of Event
    September 2, 2016
    Report Date
    September 30, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 23 SEPTEMBER 2016 THE (B)(4) PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: LATE INFECTION IN CEMENTLESS THA, 5 YEARS AFTER PRIMARY OPERATION. INFECTIONS ARE 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 28 SEPTEMBER 2016. LOT 112371: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15 SEPTEMBER 2011. EXPIRATION DATE: 2016-07-31. 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. COCR BALL HEAD 12/14 Ø 28 SIZE XL +7, CODE 01.25.014, LOT. 112911 (K072857) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03 OCTOBER 2011. EXPIRATION DATE: 2016-08-31. 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 ACETABULAR SHELL Ø 54, CODE 01.26.54MB, LOT. 112857 (K083116) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18 OCTOBER 2011. EXPIRATION DATE: 2016-09-30. 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. VERSAFITCUP DOUBLE MOBILITY HC LINER 28/DMG, CODE 01.26.2854MHC, LOT. 112900 (K092265) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20 SEPTEMBER 2011. EXPIRATION DATE: 2016-08-31. 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.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE INFECTION HAS BEEN CONFIRMED. THE PATHOGEN IS STAPHYLOCOCCUS EPIDERMIDIS. THE SURGEON REMOVED ALL HARDWARE AND INPUT AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS ARE AVAILABLE. EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643780 AMISTEM H, HA COATED STEM SIZE 6 STD CEMENTLESS FEMORAL STEM LZO MEDACTA INTERNATIONAL SA 112371

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention