BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 8

    MDR report key: 2690644 · Received August 7, 2012

    Report

    Report Number
    2249697-2012-01138
    Event Type
    Injury
    Date Received
    August 7, 2012
    Date of Event
    July 17, 2012
    Report Date
    July 17, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING OTHER HIP DEVICES WERE ALSO LISTED IN THIS REPORT: LRG TAP PRI MODE NCK 8 DEG 30 MM, CAT# NLV-300800G, LOT# 32795201; 28MM STD LFIT V40 HEAD, CAT# 6260-9-128, LOT# 34894801; RESTORATION (TM) ADM. CUP W/HA, CAT# 1235-2-502, LOT# G2958387; RESTORATION ADM X3 INS 28/50, CAT# 1236-2-850, LOT# 34169701. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PT'S PAIN. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER DUE TO HOSPITAL POLICY. ADDITIONAL INFORMATION (INCLUDING X-RAYS AND MEDICAL RECORDS ) WAS REQUESTED. SHOULD ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, PT HAS HIP PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 8 IMPLANT MEH STRYKER ORTHOPAEDICS MAHWAH NA MJKWKL

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention