BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 7

    MDR report key: 2668484 · Received July 19, 2012

    Report

    Report Number
    2249697-2012-00958
    Event Type
    Injury
    Date Received
    July 19, 2012
    Date of Event
    July 2, 2012
    Report Date
    July 2, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K092561
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING OTHER HIP DEVICES WERE ALSO LISTED IN THIS REPORT: LRG TAP PRI MOD NCK 0DEG 30MM, CAT# NLS-300000B, LOT# 32904301; TRIDENT 0DEG X3 INSERT 36MM ID, CAT# 623-00-36E, LOT# MKN7MY; DELTA V-40 CERAMIC HEAD 36/+5, CAT# 6570-0-236, LOT# 31808901. 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, REVISION OF THE RIGHT TOTAL HIP. PATIENT WAS EXPERIENCING PAIN. THEREFORE, SURGEON DECIDED TO REVISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 7 IMPLANT JDI STRYKER ORTHOPAEDICS MAHWAH NA MKM35W

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention