BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H FEMORAL STEM SIZE 5 STD

    MDR report key: 4346560 · Received December 9, 2014

    Report

    Report Number
    3005180920-2014-00176
    Event Type
    Injury
    Date Received
    December 9, 2014
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    LZO
    PMA / PMN Number
    K093944
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: AMISTEM H CEMENTLESS FEMORAL STEM SIZE 5 STD. REF. 01.18.135/LOT 130602 ((B)(4) STEMS PRODUCED): NO ANOMALIES FOUND RELATED TO THE PROBLEM OCCURRED. (B)(4) STEMS BELONGING TO THIS LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR INCIDENT. VERSAFITCUP CC LINER (K103352): REF. 01.26.3248HCT/LOT 130082 ((B)(4) LINERS PRODUCED): NO ANOMALIES FOUND RELATED TO THE PROBLEM OCCURRED. (B)(4) INSERTS BELONGING TO THIS LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR INCIDENT. CERAMIC BALL HEAD MANUFACTURED BY (B)(4) AND NOT MARKETED IN THE USA: REF. 38.49.7175.675.00/LOT 762544: (B)(4) HEAD BOUGHT BY MEDACTA AND ALL ALREADY SOLD, WITHOUT ANY OTHER SIMILAR INCIDENT. FROM THE DATA COLLECTED, WE HAVE NO EVIDENCE THAT THE EVENT IS DEVICE RELATED.

    Description of Event or Problem · 1

    IMP REFERENCE - (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792690 AMISTEM H FEMORAL STEM SIZE 5 STD FEMORAL CEMENTLESS STEM STD LZO MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1