BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER FEMORAL HEAD

    MDR report key: 1970908 · Received January 4, 2011

    Report

    Report Number
    1822565-2011-00001
    Event Type
    Malfunction
    Date Received
    January 4, 2011
    Date of Event
    November 19, 2010
    Report Date
    December 7, 2010
    Manufacturer
    ZIMMER
    Product Code
    JDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE STERILIZATION PROCESS FOR THIS DEVICE WAS VALIDATED IN ACCORDANCE WITH FDA REGULATIONS AND ISO STANDARDS TO A STERILITY ASSURANCE LEVEL (SAL) OF 1.0 X 10^ (-6) OR BETTER. THE MANUFACTURING LOT SPECIFIED IN THIS COMPLAINT WAS PROCESSED ACCORDING TO THE VALIDATED STERILIZATION PROCESS PARAMETERS AND MET ALL THE ACCEPTANCE CRITERIA FOR STERILITY RELEASE. (B)(4). THEREFORE, IT IS HIGHLY UNLIKELY THAT THE PRESENCE OF THE FOREIGN MATERIAL FOUND IN THE PACKAGE WOULD LEAD TO ANY INFECTIONS OR OTHER BIO-INCOMPATIBILITY IF THE DEVICE HAD BEEN USED. A DEFINITIVE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED WITH THE INFO PROVIDED. EVAL: 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 INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT A LINT LIKE FOREIGN SUBSTANCE WAS ADHERED TO THE INSIDE OF THE STERILE PACKAGING. THE SURGEON PROCEEDED TO IMPLANT THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER FEMORAL HEAD HIP PROSTHESIS JDI ZIMMER 61071102

    Patients

    Seq Age Sex Outcome Treatment
    1