BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN ZIMMER HIP

    MDR report key: 1872330 · Received October 12, 2010

    Report

    Report Number
    1822565-2010-00865
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Report Date
    September 14, 2010
    Manufacturer
    ZIMMER INC.
    Product Code
    JDI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: IMPLANTS HAVE BEEN IN-VIVO APPROXIMATELY 3 YEARS 5 MONTHS. SINCE NO INFO ABOUT THE IMPLANTS WAS PROVIDED, PART NUMBERS AND LOT NUMBERS CANNOT BE DETERMINED. THE IMPLANTS REMAIN IN-VIVO AND ARE NOT AVAILABLE FOR ANALYSIS. GIVEN THE INFO PROVIDED, A DEFINITIVE CAUSE FOR THE EXPERIENCE OF PAIN CANNOT BE DETERMINED. 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 INFO, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE RE-OPENED. ZIMMER, INC CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT HAS EXPERIENCED PAIN SINCE HIP SURGERY.

    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 78 YR