BEUDAMED
    FDA Adverse Event Injury Summary report: N

    28MM 0MM V40 ALUMINA HEAD

    MDR report key: 2090897 · Received May 12, 2011

    Report

    Report Number
    9616680-2011-00291
    Event Type
    Injury
    Date Received
    May 12, 2011
    Date of Event
    April 18, 2011
    Report Date
    April 18, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    LZO
    PMA / PMN Number
    K003413
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. CATALOG NUMBER AND LOT CODES OF OTHER DEVICE LISTED IN THIS REPORT: CAT # 625-0T-28D, LOT # 7964602; DESCRIPTION: TRIDENT ALUMINA INSERT. IT CANNOT BE DETERMINE WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PT'S EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "ACCORDING TO THE SURGEON, THE PT CLAIMED TO HAVE HIP PAIN. THE X-RAYS SHOWED THAT THE IMPLANTS WERE IN GOOD POSITION. PT WAS REVISED FOR HIP PAIN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 28MM 0MM V40 ALUMINA HEAD IMPLANT LZO STRYKER ORTHOPAEDICS CORK NA 6895501

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention