BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REJUVENATE STRGHT PRFIT TMZF 132 MONO STEM SIZE 6

    MDR report key: 2945685 · Received February 6, 2013

    Report

    Report Number
    0002249697-2013-00575
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Date of Event
    October 17, 2012
    Report Date
    January 28, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE PROVIDED IMPLANT SHEET INDICATED THIS DEVICE WAS OPENED DURING THE PRIMARY SURGERY BUT NOT IMPLANTED AS THE SURGEON DECIDED TO USE A LARGER SIZE IMPLANT. THERE WAS NO DEVICE FAILURE ALLEGED AT THE TIME OF USE AND NO INDICATION THAT THE SURGEON'S CHOICE TO CHANGE IMPLANT SIZE WAS DUE ANY DEFICIENCY OF THE DEVICE. BECAUSE THE DEVICE WAS NEVER IMPLANTED IT IS DETERMINED THAT THE DEVICE DID NOT INFLUENCE THE REPORTED REVISION SURGERY.

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE HAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION (INCLUDING X-RAYS AND MEDICAL RECORDS) HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A REVISION SURGERY, THIS STEM WAS IMPLANTED AND THEN EXPLANTED IMMEDIATELY BECAUSE THE SURGEON WANTED A LARGER SIZE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A REVISION SURGERY, THIS STEM WAS IMPLANTED AND THEN EXPLANTED IMMEDIATELY BECAUSE THE SURGEON WANTED A LARGER SIZE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51281 REJUVENATE STRGHT PRFIT TMZF 132 MONO STEM SIZE 6 IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH MHL507-1

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR