BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA H FEMORAL STEM

    MDR report key: 1970172 · Received January 14, 2011

    Report

    Report Number
    3005180920-2010-00010
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    May 12, 2010
    Report Date
    January 11, 2011
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW. QUADRA H FEMORAL STEM SIZE 4 - REF. (B)(4)/LOT. 083658 (B)(4). ALL PARAMETERS WERE FOUND TO BE CONFORMING TO SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING. THE WASHING CYCLE FOR METAL COMPONENTS WERE 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. ABOUT 25 STEMS BELONG TO THIS LOT HAVE BEEN IMPLANTED AND NO INCIDENTS HAVE BEEN REPORTED UP TO NOW. THE DOCUMENT REVIEW OF THE CORRELATED IMPLANTS WAS REQUIRED TO (B)(4) AS MANUFACTURER AND OWNER OF THE (B)(4) MARK OF THE TWO PIECES, ONLY DISTRIBUTED BY MEDACTA INTERNATIONAL: CERAMIC BALL HEAD 32 - REF. (B)(4)/LOT. 383269 (NOT MARKETED IN THE USA). CERAMIC LINER - REF. (B)(4)/LOT. 393561 (NOT MARKETED IN THE USA). PROTOCOLS AND ACCEPTANCE CERTIFICATES WERE REVIEWED. THE QUALITY DOCUMENTS SHOW THAT THE VALUE OBTAINED ON THE INSERT AND ON THE BALL HEAD WERE ACCORDING TO SPECIFICATION VALID AT THE TIME OF PRODUCTION. THE MICROSTRUCTURES, AS OBTAINED FROM THE QUALITY DOCUMENTS, ACCOMPLISH THE REQUIREMENTS AS SPECIFIED AT THE TIME OF PRODUCTION. THERE ARE NO INDICATIONS OF ANY PRE-EXISTING MATERIAL DEFECTS. THE REVISION SURGERY IS ASSOCIATED TO AN INFECTION EVENT. ON THE BASIS OF THE BATCH RECORDS REVIEW AND THE ABSENCE OF INFECTION EVENTS ON THE OTHER PIECES OF THE SAME LOTS, A DEVICE INVOLVEMENT IS HIGH UNLIKELY.

    Description of Event or Problem · 1

    THE PATIENT HAD PAIN SINCE FEW WEEKS AFTER PRIMARY SURGERY. THE SURGEON OBSERVED IN THE X-RAYS THAT THE STEM HAD A DISTAL PLAY. DURING REVISION SURGERY THE SURGEON NOTICED A YELLOW FLUID INTO THE JOINT. THE RESULTS OF THE SMEAR WAS (B)(6). THE FEMORAL STEM, THE LINER AND THE BALL HEAD WERE EXPLANTED. THE PATIENT WAS TREATED WITH ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUADRA H FEMORAL STEM FEMORAL STEM SIZE 4 LATERALIZED JDI MEDACTA INTERNATIONAL SA NA 083658

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention CERAMIC BALL HEAD 32: REF. (B)(4)| CERAMIC LINER: REF. (B)(4), LOT. 393561| LOT. 383269