BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H FEMORAL CEMENTLESS STEM SIZE 8 STD

    MDR report key: 4297155 · Received November 14, 2014

    Report

    Report Number
    3005180920-2014-00154
    Event Type
    Injury
    Date Received
    November 14, 2014
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    LZO
    PMA / PMN Number
    K093944
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: AMISTEM H CEMENTLESS FEMORAL STEM SIZE 8 STD: REF. 01.18.138/ LOT# 141473 ((B)(4) STEMS PRODUCED/ (B)(4) SOLD): NO ANOMALIES FOUND. AMISTEM H BROCH SIZE 8: REF. 01.18.10.108/ LOT# 1213502 ((B)(4) REUSABLE BROACHES PRODUCED): NO ANOMALIES FOUND. STEM EXTRACTOR: CODE 01.15.10.0038 - LOT# 1214007 ((B)(4) REUSABLE EXTRACTORS PRODUCED): NO ANOMALIES FOUND. FROM THE DATA COLLECTED, THERE ARE NO EVIDENCES THAT THE EVENT IS DEVICE RELATED.

    Description of Event or Problem · 1

    PLEASE REFER IMPORTER REPORT#: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738995 AMISTEM H FEMORAL CEMENTLESS STEM SIZE 8 STD FEMORAL CEMENTLESS STEM LZO MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1