BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALUMINA V40-FEMORAL HEAD 32MM, +0MM NK

    MDR report key: 3233710 · Received July 18, 2013

    Report

    Report Number
    0002249697-2013-02374
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 6, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LZO
    PMA / PMN Number
    K023901
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT WAS NOT CONFIRMED AS NO ITEMS ASSOCIATED WITH THE EVENT WERE RETURNED OR MADE AVAILABLE FOR EVALUATION AND MEDICAL RECORDS OR X-RAYS WERE MADE AVAILABLE FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORDS INDICATES ALL DEVICES ACCEPTED INTO FINAL STOCK MET SPECIFICATIONS. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THIS LOT. THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE DETERMINED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION AND NO MEDICAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT THE REPORTED DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THE COMPLAINT HISTORY REVIEW INDICATED THAT THERE WERE NO SIMILAR EVENTS FOR THE REPORTED LOT. THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE DETERMINED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION AND NO MEDICAL INFORMATION WAS PROVIDED. IF THE DEVICES AND/OR ADDITIONAL INFORMATION ARE RECEIVED, THIS INVESTIGATION WILL BE REOPENED AND RE-EVALUATED.

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS RETAINED BY THE PATIENT AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION (INCLUDING X-RAYS AND MEDICAL RECORDS) HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. DEVICE NOT RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON REVISED HIP DUE TO LEG LENGTH DISCREPANCY. ADDITIONAL INFORMATION RECEIVED FROM SALES REP ON (B)(4) 2013: PATIENTS STEM SUBSIDED. SHE HAD ALUMINA ON ALUMINA IMPLANTS IN. SURGEON DECIDED TO REVISE TO MDM. AND LONGER NECK TO ADDRESS THE LEG LENGTH DISCREPANCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON REVISED HIP DUE TO LEG LENGTH DISCREPANCY. ADDITIONAL INFORMATION RECEIVED FROM SALES REP ON (B)(6) 2013: PATIENT'S STEM SUBSIDED. SHE HAD ALUMINA ON ALUMINA IMPLANTS IN. SURGEON DECIDED TO REVISE TO MDM AND LONGER NECK TO ADDRESS THE LEG LENGTH DISCREPANCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON REVISED HIP DUE TO LEG LENGTH DISCREPANCY. ADDITIONAL INFORMATION RECEIVED FROM SALES REP ON JULY 16, 2013: PATIENTS STEM SUBSIDED. SHE HAD ALUMINA ON ALUMINA IMPLANTS IN. SURGEON DECIDED TO REVISE TO MDM AND LONGER NECK TO ADDRESS THE LEG LENGTH DISCREPANCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334998 ALUMINA V40-FEMORAL HEAD 32MM, +0MM NK IMPLANT LZO STRYKER ORTHOPAEDICS-MAHWAH 33952701

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention