BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 7

    MDR report key: 2747398 · Received September 11, 2012

    Report

    Report Number
    2249697-2012-01522
    Event Type
    Injury
    Date Received
    September 11, 2012
    Date of Event
    August 21, 2012
    Report Date
    August 21, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K092561
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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 0DEG 30MM, CAT# NLS-300000B, LOT# 32356201; DELTA V-40 CERAMIC HEAD 36/+2.5, CAT# 6570-0-536, LOT# 32905801. IT CANNOT BE DETERMINED WHICH, IF ANY, OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PT'S PAIN. AN EVALUATION OF THE REPORTED DEVICES CANNOT BE PERFORMED AS THE DEVICES WERE KEPT BY THE HOSPITAL AND WERE NOT RETURNED TO THE MANUFACTURER. HOWEVER, SOME X-RAYS AND MEDICAL RECORDS HAVE BEEN RECEIVED. WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UNEXPLAINED PAIN, LEFT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 7 IMPLANT LPH STRYKER ORTHOPAEDICS MAHWAH NA MHRMN3

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR