BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CPT HIP SYSTEM FEMORAL STEM W/ CENTRALIZER

    MDR report key: 2493972 · Received March 14, 2012

    Report

    Report Number
    2648920-2012-00057
    Event Type
    Malfunction
    Date Received
    March 14, 2012
    Date of Event
    February 14, 2012
    Report Date
    February 15, 2012
    Manufacturer
    ZIMMER
    Product Code
    JDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE ASSEMBLY/TRACEABILITY RECORDS WERE VERIFIED AND DOCUMENTED THAT THE CORRECT NUMBER OF ITEM 2 (CENTRALIZER) WAS ISSUED TO THIS WORK ORDER. NO PRODUCT OR PACKAGING WAS RETURNED FOR REVIEW. WITH THE PACKAGE BEING OPENED IN THE FIELD AND NOT BEING RETURNED, IT CANNOT BE DEFINITIVELY DETERMINED IF THE CENTRALIZER WAS PACKAGED OR NOT WITH THE STEM. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. 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 INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE CENTRALIZER WAS NOT INCLUDED WITH THE STEM. ANOTHER IMPLANT WAS OPENED TO UTILIZE THE CENTRALIZER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CPT HIP SYSTEM FEMORAL STEM W/ CENTRALIZER JDI ZIMMER 61694193

    Patients

    Seq Age Sex Outcome Treatment
    1