BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 11

    MDR report key: 2682724 · Received July 31, 2012

    Report

    Report Number
    2249697-2012-01028
    Event Type
    Injury
    Date Received
    July 31, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING OTHER HIP DEVICES WERE ALSO LISTED IN THIS REPORT: LRG TAP PRI MOD NCK 8DEG 38MM, CAT# NLV-380800Y, LOT# 29589401. RESTORATION (TM) ADM. CUP W/HA, CAT# 1235-2-621, LOT# G2848547. RESTORATION ADM X3 INS 28/62, CAT# 1236-2-862, LOT# 33079901. DELTA V-40 CERAMIC HEAD 28/+4, CAT# 6570-0-228, LOT# 35066702. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE 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: "DR. (B)(6) STATED, THE PT HAD ONSET OF PAIN STARTING (B)(6) 2011."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 11 IMPLANT MEH STRYKER ORTHOPAEDICS MAHWAH NA MHR78Y

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other