BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM C FEMORAL STEM

    MDR report key: 3001162 · Received March 7, 2013

    Report

    Report Number
    3005180920-2013-00009
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    February 4, 2013
    Report Date
    March 7, 2013
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    LZO
    PMA / PMN Number
    K103189
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: AMISTEM C CEMENTED FEMORAL STEM SIZE 1 STD- REF. 01.18.151/ LOT 122324 (34 STEMS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING. THE WASHING CYCLE FOR METAL COMPONENTS WAS RUN ACCORDING TO SPECIFICATIONS AND NO ALARM OR DEVIATION OCCURRED DURING OPERATION. THE STERILIZATION CYCLE WAS PERFORMED ACCORDING TO SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. THE 10 STEMS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED AND NO OTHER INCIDENTS HAVE BEEN REPORTED UP TO NOW. COCR FEMORAL HEAD (K080885): REF. 01.25.030- LOT 123105 (30 HEADS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING. THE WASHING CYCLE FOR METAL COMPONENTS WAS RUN ACCORDING TO SPECIFICATIONS AND NO ALARM OR DEVIATION OCCURRED DURING OPERATION. THE STERILIZATION CYCLE WAS PERFORMED ACCORDING TO SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. THE 19 HEADS OF THIS LOT HAVE BEEN ALREADY IMPLANTED WITHOUT ANY OTHER SIMILAR INCIDENT. FROM THE DATA COLLECTED, THERE IS NO EVIDENCE THAT THE INFECTION IS DEVICE RELATED.

    Description of Event or Problem · 1

    REVISION SURGERY DUE TO INFECTION 2 MONTHS POST OP. THE INFECTION WAS DETECTED DURING A CONSULTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98323 AMISTEM C FEMORAL STEM FEMORAL STEM SIZE 1 STD CEMENTED LZO MEDACTA INTERNATIONAL, SA 122324

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention (K080885)| COCR BALL HEAD 36 S: CODE 01.25.030 LOT 123105