BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H FEMORAL STEM SIZE 3 STD

    MDR report key: 5222596 · Received November 13, 2015

    Report

    Report Number
    3005180920-2015-00265
    Event Type
    Injury
    Date Received
    November 13, 2015
    Date of Event
    October 15, 2015
    Report Date
    November 13, 2015
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2015 WE WERE INFORMED THAT THE EXPLANT IS NOT AVAILABLE FOR INVESTIGATION. BATCH REVIEW PERFORMED ON 10 NOVEMBER 2015: LOT 150848: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15 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. ON (B)(6) 2015 THE MEDICAL AFFAIRS MADE THE FOLLOWING ANALYSIS: THE ROOT CAUSE FOR THIS EARLY CASE OF SUBSIDENCE IS PERIPROSTHETIC FRACTURE. THERE ARE NO INDICATIONS AS TO THE POSSIBLE REASON FOR SUCH AN EVENT. IT MAY HAVE BEEN A TRAUMATIC EVENT OR A HIDDEN IATROGENIC FRACTURE, WHICH IS A KNOWN POSSIBLE COMPLICATION OF TOTAL HIP ARTHROPLASTY. ON 12 NOV 2015 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ABOVE REPORTED. ON 13 NOV 2015 IT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED. NOT AVAILABLE.

    Description of Event or Problem · 1

    STEM SUBSIDED 1,5 CM, PERIPROSTHETIC FRACTURE. THE SURGEON PUT THE CERCLAGE AND A CEMENTED STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753132 AMISTEM H FEMORAL STEM SIZE 3 STD FEMORAL CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 150848

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention