BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H FEMORAL STEM

    MDR report key: 1970162 · Received January 14, 2011

    Report

    Report Number
    3005180920-2010-00028
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    October 13, 2010
    Report Date
    January 11, 2011
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: (B)(4). THE BATCH RECORD REVIEW OF THE LOT 101029 (60 PIECES PRODUCED) HAS BEEN CARRIED OUT: ALL THE VALUES WERE FOUND TO BE CONFORMING TO SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. FIFTY THREE PIECES OF THE 60 PRODUCED WERE ALREADY IMPLANTED AND ONE OTHER COMPLAINT (# 860-10) REGARDING THIS LOT WAS RECEIVED: SAME PROBLEM OF PERIPROSTHETIC FRACTURE FEW DAYS AFTER THE SURGERY, FIXED WITH A CABLE WITHOUT REVISION OF THE IMPLANT. CHECKING THE POST-OPERATIVE X-RAYS, NO ANOMALIES WERE PRESENT. THERE ARE NO EVIDENCES THAT THE FRACTURE IS DEVICE RELATED; THIS INJURY IS A KNOWN COMPLICATION OF TOTAL HIP ARTHROPLASTY.

    Description of Event or Problem · 1

    THE PT FELT PAIN THREE DAYS AFTER THE SURGERY DURING MOBILIZATION ACTIVITIES AND WAS DETECTED A PERIPROSTHETIC FRACTURE. A REVISION SURGERY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMISTEM H FEMORAL STEM FEMORAL STEM SIZE 2 STANDARD LZO MEDACTA INTERNATIONAL SA 101029

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention