BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - RIGHT TOTAL HIP REPLACEMENT

    MDR report key: 1890014 · Received November 1, 2010

    Report

    Report Number
    2249697-2010-01434
    Event Type
    Injury
    Date Received
    November 1, 2010
    Date of Event
    August 17, 2009
    Report Date
    October 6, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER AS IT IS IMPLANTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THEN IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "PT HAD A RIGHT TOTAL HIP REPLACEMENT DONE. EVER SINCE THE PT HAD HIS SURGERY HE HAS BEEN EXPERIENCING SEVERE PAIN AND IS UNABLE TO WALK WITHOUT A WALKER. HE CAN WALK A FEW STEPS AND THEN HAS TO SIT DOWN. PT NOW USES A WHEEL CHAIR FOR MOST OF HIS TRANSPORTATION. PT FOLLOWED UP WITH THIS SURGEON ON MULTIPLE OCCASIONS REGARDING HIS PAIN. X-RAYS WERE TAKEN; SURGEON STATED THAT THE IMPLANTS LOOKED TO BE IN PLACE AND THE PT WAS PRESCRIBED PAIN MEDICATION. PT RECENTLY VISITED HIS SURGEON ABOUT A MONTH AGO AND THE DR. STATED THAT THE PT MAY HAVE A DEEP INFECTION AND THE ONLY WAY TO TELL WOULD BE TO OPERATE. PT STATED THAT IT WAS OK TO CONTACT HIS SURGEON."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK - RIGHT TOTAL HIP REPLACEMENT IMPLANT JDI STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Other| R