BEUDAMED
    FDA Adverse Event Injury Summary report: N

    26MM +16 5-40 TAPER VIT HEAD OBSOLETE RUTHERFORD

    MDR report key: 3013382 · Received March 20, 2013

    Report

    Report Number
    0002249697-2013-01050
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 26, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K936127
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS DISCARDED BY HOSPITAL AND WAS NOT RETURNED TO THE MANUFACTURER. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. NOT RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS REPORTED FOR THE REPORTED MANUFACTURING LOT THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE OF THE REPORTED EVENT DETERMINED DUE TO THE MINIMAL INFORMATION RECEIVED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF DEVICES AND / OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    DURING A BOOKED REVISION, NO IMPLANT STICKERS WERE AVAILABLE OR COULD BE LOCATED. A CHANGE OF FEMORAL HEAD ON A STEM WAS UNDERTAKEN. THE HEAD REMOVED DURING THE REVISION WAS NOTED TO BE V40, IMPLANTED 1999 OR 2000 DURING A PREVIOUS ACETABULAR REVISION. STEM IMPLANTED EITHER AT SAME TIME OR IN PRIMARY SURGERY AROUND 1993 APPROXIMATELY. EXACT IMPLANT HISTORY IS UN CLEAR AS PATIENT'S NOTES AND HOSPITAL RECORDS ARE NO LONGER AVAILABLE. DURING THIS CURRENT REVISION THE FEMORAL HEAD WAS EXCHANGED AND AN ACETABULAR REVISION WAS UNDERTAKEN. A CUSTOM ACETABULAR CAGE WAS INSERTED, WITH OUR CEMENTED CONSTRAINED LINER. AND A NEW V40 HEAD WAS IMPLANTED ON TO THE STEM.

    Description of Event or Problem · 1

    DURING A BOOKED REVISION, WHERE NO IMPLANT STICKERS WERE AVAILABLE OR COULD BE LOCATED. A CHANGE OF FEMORAL HEAD ON A STEM WAS UNDERTAKEN. THE HEAD REMOVED DURING THE REVISION WAS NOTED TO BE V40, IMPLANTED 1999 OR 2000 DURING A PREVIOUS ACETABULAR REVISION. STEM IMPLANTED EITHER AT SAME TIME OR IN PRIMARY SURGERY AROUND 1993 APPROXIMATELY. EXACT IMPLANT HISTORY IS UN CLEAR AS PATIENTS NOTES AND HOSPITAL RECORDS ARE NO LONGER AVAILABLE. DURING THIS CURRENT REVISION THE FEMORAL HEAD WAS EXCHANGED AND AN ACETABULAR REVISION WAS UNDERTAKEN. A CUSTOM ACETABULAR CAGE WAS INSERTED, WITH OUR CEMENTED CONSTRAINED LINER. AND A NEW V40 HEAD WAS IMPLANTED ON TO THE STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116739 26MM +16 5-40 TAPER VIT HEAD OBSOLETE RUTHERFORD IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention