BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H FEMORAL STEM

    MDR report key: 2096681 · Received May 5, 2011

    Report

    Report Number
    3005180920-2011-00020
    Event Type
    Injury
    Date Received
    May 5, 2011
    Date of Event
    April 2, 2011
    Report Date
    May 5, 2011
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SURGEON PERFORMED THE PRIMARY SURGERY ON THE (B)(6) 2011: THE BROACHED A SIZE 2 BUT WHEN HE IMPLANTED THE SIZE 2, IT SUNK TOO DEEP SO HE REBROACHED TO A SIZE 4 AND IMPLANTED A SIZE 4. ON THE 2ND OF (B)(6), HE DETECTED THE FEMUR FRACTURE; HE BROUGHT THE PT BACK INTO THEATRE AND PUT CIRCLAGE WIRES TO HOLD IT IN PLACE. THE MANUFACTURING DOCUMENTS (BATCH RECORD) OF THE HA COATED STEMS SIZE 4 (THE ONE IMPLANTED) AND SIZE 2 (THE ONES INITIALLY CHOSEN, BUT NOT IMPLANTED) WERE REVIEWED; ALL THE VALUES WERE FOUND TO BE CONFORMING TO SPECIFICATIONS IN FORCE AT THE TIME OF PRODUCTION FOR BOTH THE LOTS. ADDITIONALLY: LOT. 103440 OF REF. (B)(4) COMPRISES 60 STEMS RELEASED ON THE MARKET IN (B)(4) 2010. TO DATE, 37 STEMS WERE IMPLANTED AND NO OTHER SIMILAR EVENTS REPORTED. LOT 104275 OF REF. (B)(4) COMPRISES 55 STEMS RELEASED ON THE MARKET IN (B)(4) 2011. TO DATE, 35 STEMS WERE IMPLANTED AND NO OTHER SIMILAR EVENTS WERE REPORTED. THERE ARE NO EVIDENCES THAT THE FRACTURE IS DEVICE RELATED; THIS INJURY IS A KNOWN COMPLICATION OF TOTAL HIP ARTHROPLASTY.

    Description of Event or Problem · 1

    THE PT HAD A FEMUR FRACTURE. THE SURGEON PUT A CIRCLAGE WIRE TO HOLD THE FRACTURE IN PLACE. THE EVENT OCCURRED 2 DAYS AFTER PRIMARY SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMISTEM H FEMORAL STEM FEMORAL STEM SIZE 4 STANDARD LZO MEDACTA INTERNATIONAL SA 103440

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention AMISTEM H FEMORAL STEM STD SIZE 2: REF. (B)(4)| LOT. 104275