BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 7

    MDR report key: 2585160 · Received May 21, 2012

    Report

    Report Number
    2249697-2012-00650
    Event Type
    Injury
    Date Received
    May 21, 2012
    Date of Event
    May 8, 2012
    Report Date
    May 8, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING OTHER HIP DEVICES WERE ALSO LISTED IN THIS REPORT: LRG TAP PRI MOD NCK 16DEG 30MM, CAT# NLS-301600P, LOT# 31894002; RESTORATION ADM. CUP W/HA, CAT# 1235-2-501, LOT# G2961009; ALUMINA C-TAPER HEAD 32MM/+5, CAT# 17-3205E, LOT# 272842; UNK POLY. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S PAIN. WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "THE PATIENT WAS HAVING PAIN SO THE SURGEON REVISED."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention