BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ZIMMER HIP

    MDR report key: 2191031 · Received July 29, 2011

    Report

    Report Number
    1822565-2011-01740
    Event Type
    Injury
    Date Received
    July 29, 2011
    Report Date
    July 1, 2011
    Manufacturer
    ZIMMER INC
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE OPERATIVE NOTE STATED THAT THE FEMORAL STEM WAS COMPLETELY SOUND SO ONLY THE SHELL AND LINER WERE REVISED. A REPORT REVIEWING TISSUE FROM THE LEFT HIP WAS RECEIVED REPORTING NO METAL FRAGMENTS AND ASEPTIC LYMPHOCYTE VASCULITIS ASSOCIATED LESIONS (AVAL) THAT IS "QUITE LOW INTENSITY IN COMPARISON TO CASES ILLUSTRATED IN THE PUBLISHED REPORTS OF THIS HISTOLOGY." NO DEVICES OR PHOTOS WERE RECEIVED; THEREFORE, THE CONDITION OF THE COMPONENTS IS UNK. SURGICAL NOTES WERE NOT PROVIDED, IT IS UNK WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. ADHERENCE TO REHABILITATION PROTOCOL IS UNK. IT IS POSSIBLE THAT THE "PSEUDO-TUMOUR" REMOVED DURING REVISION WAS CAUSING THE PT PAIN. WITH THE INFORMATION PROVIDED, THE EXACT CAUSE CANNOT BE DETERMINED WITH CERTAINTY. EVALUATION: REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE AVAILABLE INFORMATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT IS EXPERIENCING WEAKNESS, INSTABILITY AND PAIN, AND THAT THERE IS A LUMP IN THE LEFT GROIN LYMPH NODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN ZIMMER HIP HIP PROSTHESIS JDI ZIMMER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other