BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 7

    MDR report key: 2115074 · Received May 31, 2011

    Report

    Report Number
    2249697-2011-00789
    Event Type
    Injury
    Date Received
    May 31, 2011
    Date of Event
    May 6, 2011
    Report Date
    May 6, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LZO
    PMA / PMN Number
    K071082
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: CAT# NLV-340800Y, LOT# 29589302, DESCRIPTION: UNK REJUVENATE MODULAR NECK 34MM 8 DEGREE ANT 132 DEG. CAT# 1235-2-502, LOT# 02940825, DESCRIPTION: RESTORATION ADM. CUP W/HA. CAT# 1236-2-850, LOT# 3369560, DESCRIPTION: RESTORATION ADM X3 INS 28/50. CAT# 6570-0-128, LOT# 573280, DESCRIPTION: DELTA V-40 CERAMIC HEAD 28/0. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PT'S PAIN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "PT WAS REVISED DUE TO PERSISTENT HIP PAIN AND ELEVATED METAL ION LEVELS. ALL COMPONENTS WERE REVISED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 7 IMPLANT LZO STRYKER ORTHOPAEDICS MAHWAH NA MJD7JV

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other| R