BEUDAMED
    FDA Adverse Event Other Summary report: N

    ASR PROSTHESIS

    MDR report key: 1133923 · Received August 14, 2008

    Report

    Report Number
    MW5008072
    Event Type
    Other
    Date Received
    August 14, 2008
    Report Date
    August 14, 2008
    Product Code
    JDI
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT HAS COME TO MY ATTENTION THAT WE IN ORTHOPEDICS HAVE HAD A PROBLEM WITH A CERTAIN PROSTHESIS PROVIDED TO US IN THE HOSP. I HAVE ENUMERATED CASES STARTING FROM THE BEGINNING OF THE YEAR TO THE PRESENT. WE HAVE DONE EIGHTY-ONE HIP REPLACEMENTS USING THE ASR PROSTHESIS FROM DEPUY. OUT OF THOSE EIGHTY-ONE, WE HAVE REVISED EIGHT DUE TO LOOSENING OF THE ACETABULAR COMPONENT, AND FOURTEEN MORE, THAT ARE POSSIBLY LOOSE. IN EACH INSTANCE, THERE WAS NO RADIOGRAPHIC EVIDENCE OF LOOSENESS. THE PT COMPLAINED OF PAIN IN THE GROIN. THERE WAS NO SIGN OF INFECTION. AT THE TIME OF SURGERY, THE PROSTHESIS COULD, WITH RELATIVE EASE, BE TAPPED OUT OF ITS BED. WHERE BONE SHOULD HAVE GROWN INTO THE PROSTHESIS, THERE WAS SCAR TISSUE AND IT WAS NOT SOLID. SOME OF THE ENGINEERS FROM DEPUY HAVE BEEN DOWN AND REVIEWED SOME OF THE X-RAYS. IN SUMMARY, WE HAVE DONE EIGHTY-ONE CUPS FOR TOTAL HIPS SINCE 2007. OUT OF THAT EIGHT-ONE, EIGHT HAVE BEEN REVISED DUE TO LOOSENING. THERE ARE FURTHER FOURTEEN THAT ARE POSSIBLY LOOSE. THIS HAS BEEN DONE BY SEVEN PHYSICIANS IN ORTHOPEDICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR PROSTHESIS PROSTHESIS JDI

    Patients

    Seq Age Sex Outcome Treatment
    1