BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN STEM

    MDR report key: 2872157 · Received December 6, 2012

    Report

    Report Number
    2249697-2012-02586
    Event Type
    Injury
    Date Received
    December 6, 2012
    Date of Event
    June 1, 2012
    Report Date
    November 14, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE PATIENT WAS UNABLE TO IDENTIFY THE DEVICES IMPLANTED, BUT BELIEVES THEM TO BE EITHER REJUVENATE OR ABG II. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE REMAINED IMPLANTED AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION PERTAINING TO THE DEVICE REFERENCED IS THIS REPORT (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT IS REPORTED, PATIENT RECEIVED THE LETTER REGARDING THE RECALL FROM THE SURGEON. THE PATIENT HAS EXPERIENCED SPORADIC PAIN, ACHING AND WEAKNESS IN THE RIGHT HIP AT THE IMPLANT SITE SINCE (B)(6) 2012. THE PAIN IS NOT SEVERE BUT SOMETIMES CAUSES HIM TO WALK WITH A LIMP. THE PATIENT SAW HIS SURGEON ON (B)(6) 2012 AND X-RAYS WERE TAKEN. HE WILL SEE HIS SURGEON EVERY SIX MONTHS FOR FOLLOW UP OR SOONER IF THE EXPERIENCES PAIN OR DISCOMFORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN STEM IMPLANT MEH STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other| R