BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATURAL-HIP SYSTEM COLLARED STEM POROUS

    MDR report key: 2051498 · Received April 7, 2011

    Report

    Report Number
    1822565-2011-00878
    Event Type
    Injury
    Date Received
    April 7, 2011
    Date of Event
    March 4, 2010
    Report Date
    March 14, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: SAMPLE LABEL SHEETS WERE ANALYZED. THE MAIN LABEL ON THE BOX OF A LEFT OR RIGHT STEM READS EITHER LEFT OR RIGHT IN TWO PLACES. PT LABELS OF QUANTITY SIX ARE ALSO APPLIED TO THE OUTER TYVEK LID INSIDE THE BOX. THESE LABELS ALSO READ LEFT OR RIGHT. IT IS SPECIFIED THAT THE STEM ITSELF ALSO BE MARKED ON THE FLAT AREA ON THE PROXIMAL END WITH EITHER L OR R. BY REVIEWING THE LABELING AND THE PART DESIGN, IT WAS CONFIRMED THAT THERE ARE MULTIPLE LOCATIONS WHERE A LEFT VERSUS RIGHT STEM IS IDENTIFIED. DURING SURGERY, THERE ARE TYPICALLY MULTIPLE PEOPLE IN ATTENDANCE TO OBSERVE THESE PART IDENTIFICATIONS. A DEFINITIVE ROOT CAUSE FOR THIS EVENT CANNOT BE DETERMINED. 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 INFO, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT A LEFT NATURAL HIP STEM WAS IMPLANTED IN THE RIGHT HIP OF THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NATURAL-HIP SYSTEM COLLARED STEM POROUS HIP PROSTHESIS JDI ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other