BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H FEMORAL STEM

    MDR report key: 2427520 · Received January 11, 2012

    Report

    Report Number
    3005180920-2012-00001
    Event Type
    Injury
    Date Received
    January 11, 2012
    Date of Event
    December 12, 2011
    Report Date
    January 11, 2012
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: AMISTEM H FEMORAL STEM SIZE 3 - (B)(4)/LOT 101307 (23 STEMS PRODUCED - ALL ALREADY IMPLANTED): ALL PARAMETERS WERE FOUND TO BE CONFORMING TO SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING. THE WASHING CYCLE FOR METAL COMPONENTS WAS RUN ACCORDING TO SPECIFICATIONS AN NO ALARM OR DEVIATION OCCURRED DURING OPERATION. THE STERILIZATION CYCLE WAS PERFORMED ACCORDING TO SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. (B)(4) - COCR FEMORAL BALL HEAD - (B)(4)/LOT 110374 (39 BALL HEADS PRODUCTS - 35 ALREADY IMPLANTED): ALL PARAMETERS WERE FOUND TO BE CONFORMING TO 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. (B)(4) - VERSAFTICUP DM HX LINER REF. (B)(4)/LOT 103410 (36 LINERS PRODUCED - 30 ALREADY IMPLANTED): ALL PARAMETERS WERE FOUND TO BE CONFORMING TO SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING . THE WASHING CYCLE FOR PLASTIC 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. ON THE BASIS OF THE DATA COLLECTED, A DEVICE INVOLVEMENT IN THE INFECTION OCCURRED IS HIGHLY UNLIKELY.

    Description of Event or Problem · 1

    IMPLANTS WERE EXPLANTED DUE TO A PT INFECTION, AND A CEMENT PLUG WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMISTEM H FEMORAL STEM FEMORAL STEM SIZE 3 STANDARD LZO MEDACTA INTERNATIONAL SA 101307

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention COCR BALL HEAD (B)(4) LOT. 110374| VERSAFITCUP DM LINER (B)(4) LOT.103410