BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 7

    MDR report key: 2664916 · Received July 17, 2012

    Report

    Report Number
    2249697-2012-00943
    Event Type
    Injury
    Date Received
    July 17, 2012
    Date of Event
    June 29, 2012
    Report Date
    June 29, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K09256
    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 0 DEG 34MM, CAT# NLS-340000B, LOT# NLS-340000B; DELTA V-40 CERAMIC HEAD 36/+2,5, CAT# 6570-0-536, LOT# 34887001; TRIDENT 10 DEG X3 INSERT 36MM ID, CAT# 623-10-36E, LOT# MJT49H. 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 REVISED DUE TO PAIN.

    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 MJK9NW

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention