BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REJUVENATE STEM #10

    MDR report key: 2717950 · Received August 23, 2012

    Report

    Report Number
    2249697-2012-01362
    Event Type
    Injury
    Date Received
    August 23, 2012
    Date of Event
    August 2, 2012
    Report Date
    August 2, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LXH
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER AND LOT CODE OF OTHER DEVICE LISTED IN THIS REPORT: CAT # NLS-380000B, LOT # 37413001, DESCRIPTION: LRG TAP PRI MOD NCK 0DEG 38MM. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING HIP PAIN 3 MONTHS AFTER INITIAL SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REJUVENATE STEM #10 IMPLANT LXH STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other| R