BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H FEMORAL CEMENTLESS STEM SIZE 4 STD

    MDR report key: 3810237 · Received April 28, 2014

    Report

    Report Number
    3005180920-2014-00047
    Event Type
    Injury
    Date Received
    April 28, 2014
    Date of Event
    March 27, 2014
    Report Date
    April 28, 2014
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    LZO
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: AMISTEM H CEMENTLESS FEMORAL STEM SIZE 4 STD: REF. 01.18.134 /LOT 113575 ((B)(4)ITEMS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECS VALID AT THE TIME OF MFG, INCLUDING WASHING AND STERILIZATION PROCEDURES. (B)(4) STEMS BELONGING TO THIS LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR INCIDENT. VERSAFITCUP CC TRIO CUP CEMENTLESS SIZE 52: REF. 01.26.45.0052 / LOT 113307 ((B)(4) CUPS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECS VALID AT THE TIME OF MFG, INCLUDING WASHING AND STERILIZATION PROCEDURES. (B)(4) CUPS BELONGING TO THIS LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR INCIDENT. FURTHER INFO RECEIVED FROM THE HOSPITAL: "ACCORDING TO THE SPECT-CT WE WERE FIRST THINKING ABOUT A STEM TILTING OR LOOSENING, BUT IT WAS NOT THE CASE. IT WAS STRONGLY FIXED IN THE BONE. THE CUP WAS PROBABLY A BIT TO VERTICAL AND COULD FINALLY ALSO BE THE SOURCE OF THE PAIN, REASON WHY DECIDED TO EXPLANT ALL THE COMPONENTS AND REIMPLANT NEW ONES". FROM THE DATA COLLECTED, THERE ARE NO EVIDENCE THAT THE EVENT IS DEVICE RELATED.

    Description of Event or Problem · 1

    REF IMP# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253657 AMISTEM H FEMORAL CEMENTLESS STEM SIZE 4 STD FEMORAL CEMENTLESS STEM LZO MEDACTA INTERNATIONAL, SA 113575

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention VERSAFITCUP CC TRIO CUP SIZE 52 (K103352):| CODE 01.26.45.0052 - LOT 113307