BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA S STD FEMORAL STEM

    MDR report key: 2613789 · Received September 29, 2009

    Report

    Report Number
    3005180920-2009-00004
    Event Type
    Injury
    Date Received
    September 29, 2009
    Date of Event
    August 31, 2009
    Report Date
    August 31, 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 083531 (B)(4) CONFORM TO THE SPECIFICATION VALID AT THE TIME OF MANUFACTURE.

    Description of Event or Problem · 1

    SURGEON STARTED WITH THE STANDARD SIZE 0 BROACH AND CONTINUED BROACHING UP TO SIZE 4. THE FINAL IMPLANT WAS A SIZE 4 AND A SMALL CRACK WAS NOTICED IN THE CALCAR BONE. THE CRACK WAS CABLED. THE SURGEON DID NOT HEAR THE CRACK SO HE WAS UNABLE TO TELL EXACTLY WHEN IT OCCURRED BUT IT MAY HAVE HAPPENED DURING HIP REDUCTION. THE PT WAS PUT ON RESTRICTION ACTIVITY AFTER SURGERY. THE CRACK OCCURRED IN THE INITIAL SURGERY. AFTER REVIEWING THE INTER- OPERATIVE X-RAYS, THE SURGEON IDENTIFIED ANOTHER CRACK IN THE DISTAL PORTION OF THE FEMUR. THE PT WAS BROUGHT BACK TO THE OPERATING ROOM TO REMOVE THE ORIGINAL STEM AND REPLACE IT WITH A LONGER REVISION STEM. 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 083531

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention S/ 28MM/ OFFSET: -3.5MM: 133-2847, LOT 00003732| PIVOT BIPOLAR CUP: 28 X 47MM| FEMORAL HEAD: 01.25.011, LOT 091340