BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 8

    MDR report key: 2740429 · Received September 5, 2012

    Report

    Report Number
    2249697-2012-01478
    Event Type
    Injury
    Date Received
    September 5, 2012
    Date of Event
    August 9, 2012
    Report Date
    August 9, 2012
    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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THE REVISION WAS NOT PROVIDED. THE CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: CAT # NLV-340800Y, LOT # 31618301, DESCRIPTION: LRG TAP PRI MOD NECK 8DEG 34MM, CAT # 6260-5-128, LOT # 33490103, DESCRIPTION: 28MM STD V40 TAPER VIT HEAD, CAT # 1235-2-850, LOT # G2139065, DESCRIPTION: RESTORATION (TM) ADM. INSERT, CAT # 6570-0-136, LOT # 36591901, DESCRIPTION: DELTA V-40 CERAMIC HEAD 36/0. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PT'S EXPERIENCE. ADD'L INFO HAS BEEN REQUESTED AND IF REC'D, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    A REVIEW OF REJUVENATE STEM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 8 IMPLANT LZO STRYKER ORTHOPAEDICS MAHWAH NA MHR39E

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other| R