BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 10

    MDR report key: 2677501 · Received July 27, 2012

    Report

    Report Number
    2249697-2012-01013
    Event Type
    Injury
    Date Received
    July 27, 2012
    Date of Event
    July 9, 2012
    Report Date
    July 9, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K092561
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING OTHER HIP DEVICE WAS ALSO LISTED IN THIS REPORT: LRG TAP PRI MOD NCK 16DEG 42MM, CAT# NLS-421600P, LOT# 26409201. IT CANNOT BE DETERMINED WHICH, IF ANY OF THE REPORTED DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PT'S PAIN. AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE REMAINED IMPLANTED IN THE PT AND WAS NOT RETURNED TO THE MFR. ADD'L INFO (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. SHOULD ADD'L INFO BECOME AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, PT STARTED EXPERIENCING HIP PAIN IN (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 10 IMPLANT MEH STRYKER ORTHOPAEDICS MAHWAH NA NYMMJE

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other