BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA V-40 CERAMIC HEAD 32/+4

    MDR report key: 3666715 · Received March 7, 2014

    Report

    Report Number
    0002249697-2014-00669
    Event Type
    Injury
    Date Received
    March 7, 2014
    Date of Event
    February 10, 2014
    Report Date
    February 10, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LZO
    PMA / PMN Number
    K052718
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION BECAUSE THE HOSPITAL RETAINED IT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. HOSPITAL RETAINED.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING LIMB LENGTH DISCREPANCY INVOLVING A CERAMIC HEAD WAS REPORTED. THE EVENT WAS NOT CONFIRMED. A VISUAL, FUNCTIONAL AND DIMENSIONAL INSPECTION COULD NOT BE PERFORMED DUE TO HOSPITAL POLICY. MEDICAL RECORDS INDICATED THAT INSUFFICIENT INFORMATION WAS RECEIVED FOR REVIEW WITH A CLINICIAN CONSULTANT. DEVICE HISTORY REVIEW COULD NOT BE PERFORMED AS THE LOT ID IS INVALID. A COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED AS THE LOT ID IS INVALID. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HEAD EXCHANGE ON A RIGHT TOTAL HIP. THE PATIENT COMPLAINED OF LEG LENGTH DISCREPANCY. SURGEON REMOVED FEMORAL HEAD AND PUT IN A SHORTER HEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HEAD EXCHANGE ON A RIGHT TOTAL HIP. THE PATIENT COMPLAINED OF LEG LENGTH DISCREPANCY. SURGEON REMOVED FEMORAL HEAD AND PUT IN A SHORTER HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140301 DELTA V-40 CERAMIC HEAD 32/+4 IMPLANT LZO STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R