BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H FEMORAL CEMENTLESS STEM SIZE 1 STD

    MDR report key: 3724682 · Received February 27, 2014

    Report

    Report Number
    3005180920-2014-00020
    Event Type
    Injury
    Date Received
    February 27, 2014
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    LZO
    PMA / PMN Number
    K121011
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: AMISTEM H COLLARED CEMENTLESS FEMORAL STEM SIZE 1 STD: REF. 01.18.231 / LOT 124020 ((B)(4) STEMS PRODUCED / (B)(4)SOLD): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING, INCLUDING WASHING AND STERILIZATION PROCEDURES. MECTACER BIOLOX DELTA BALL HEAD SIZE 32 S (K112115): REF. 01.29.204 / LOT 125384 ((B)(4) HEADS PRODUCED / (B)(4) SOLD): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING, INCLUDING WASHING AND STERILIZATION PROCEDURES. VERSAFITCUP CC TRIO ACETABULAR SHELL O 46 (K103352): REF. 01.26.45.0046 / LOT 130751 ((B)(4) CUPS PRODUCED / (B)(4) SOLD): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING, INCLUDING WASHING AND STERILIZATION PROCEDURES. VERSAFITCUP CC HC UHMWPE LINER (K120531): REF. 01.26.3239HCT / LOT 132703 ((B)(4) LINERS PRODUCED / (B)(4) SOLD): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING, INCLUDING WASHING AND STERILIZATION PROCEDURES. FROM THE DATA COLLECTED, THERE ARE NO EVIDENCES THAT THE EVENT IS DEVICE RELATED.

    Description of Event or Problem · 1

    REF IMPORTER REPORT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122126 AMISTEM H FEMORAL CEMENTLESS STEM SIZE 1 STD FEMORAL COLLARED CEMENTLESS STEM LZO MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1