BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H CEMENTLESS STEM SIZE 2 STD

    MDR report key: 5188463 · Received October 29, 2015

    Report

    Report Number
    3005180920-2015-00253
    Event Type
    Injury
    Date Received
    October 29, 2015
    Date of Event
    September 26, 2015
    Report Date
    January 27, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 27 OCTOBER 2015: LOT 134165: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30 OCTOBER 2013. EXPIRATION DATE: 2018-09-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED ISSUE. COCR BALL HEAD 12/14 Ø 28 SIZE L +3.5 CODE 01.25.013 LOT. 080587/T (K072857): LOT 080587/T: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30 OCTOBER 2013. EXPIRATION DATE: 2018-09-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED ISSUE. ON OCTOBER 09TH 2015 WE WERE INFORMED THAT THE PATHOGEN IS NOCARDIA SPECIES.

    Additional Manufacturer Narrative · 1

    ON 28 DEC 2015 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INITIAL REPORT. ON 29 DEC 2015 THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2014 PATIENT HAD PRIMARY HIP SURGERY. ON (B)(6) 2015 (MDR 2015-00212) PATIENT HAD REVISION OF THE BALL HEAD, LINER AND ACETABULAR CUP DUE TO LOOSENING. THE SURGEON USED A MEDACTA BALL HEAD WITH A NON MEDACTA LINER AND ACETABULAR CUP. ON (B)(6) 2015 THE MEDACTA BALL HEAD AND STEM WERE REMOVED ALONG WITH THE CUP AND LINER. ANTIBIOTIC SPACERS WERE IMPLANTED DUE TO INFECTION. PATIENT REQUESTED TO KEEP PRODUCT SO EXPLANTS WILL NOT BE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    717085 AMISTEM H CEMENTLESS STEM SIZE 2 STD FEMORAL CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 134165

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention