BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA S STD FEMORAL STEM

    MDR report key: 2613796 · Received October 20, 2009

    Report

    Report Number
    3005180920-2009-00005
    Event Type
    Injury
    Date Received
    October 20, 2009
    Date of Event
    September 21, 2009
    Report Date
    September 21, 2009
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    JDI
    PMA / PMN Number
    K072857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MFG RECORDS AND QUALITY DOCUMENTS WERE REVIEWED. THE MFG AND QUALITY DOCUMENT REVIEW CONFIRMED THAT ALL IMPLANTS RELEASED TO THE FIELD OF LOT NUMBER 082250 (15 IMPLANTS MFG AND 11 SENT TO MEDACTA USA) CONFORM TO THE SPECIFICATION VALID AT THE TIME OF MFR.

    Description of Event or Problem · 1

    SURGEON STARTED WITH THE STANDARD SIZE 0 BROACH AND CONTINUED BROACHING UP TO SIZE 3. THE FINAL IMPLANT WAS A SIZE 3 AND THE SURGEON HEARD A CRACK. A SLIGHT FRACTURE OF THE CALCAR BONE. THE CRACK WAS REPAIRED WITH A CABLE AND THE CASE WAS FINISHED SUCCESSFULLY. THE PT WAS PUT ON RESTRICTED ACTIVITY AFTER SURGERY AND OBSERVED CLOSELY. THERE IS NO ADDITIONAL MEDICAL INTERVENTION OR REVISION SURGERY EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUADRA S STD FEMORAL STEM FEMORAL STEM JDI MEDACTA INTERNATIONAL, SA NA 082250

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention LOT 091605| COTYLE VERS., LINER 54MM X 28: 01.26.2854M,| LOT 091991| COTYLE VERS., CUP METAL BACK 54MM: 01.26.54MB,| LOT 091277| BIOLOX FEMORAL HEAD, M/ 28MM: 38.39.7175.255.00,