BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HG MULTILOCK FEMORAL HIP STEM

    MDR report key: 2003564 · Received February 22, 2011

    Report

    Report Number
    1822565-2011-00369
    Event Type
    Injury
    Date Received
    February 22, 2011
    Date of Event
    January 19, 2011
    Report Date
    January 25, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A FOREIGN SOURCE WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVALUATION SUMMARY: PATIENT DEMOGRAPHICS SUCH AS HEIGHT, WEIGHT, AND ACTIVITY LEVEL ARE UNKNOWN. THE STEM WAS IN VIVO FOR OVER 15 YEARS. THE LINER AND HEAD WERE IMPLANTED DURING FIRST STAGE OF REVISION, PUTTING THEM IN VIVO FOR APPROXIMATELY 5 1/2 MONTHS. X-RAYS AND SURGICAL NOTES WERE NOT PROVIDED. THE STERILIZATION PROCESS FOR THESE DEVICES 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 LOTS SPECIFIED IN THIS COMPLAINT WERE PROCESSED ACCORDING TO THE VALIDATED STERILIZATION PROCESS PARAMETERS AND MET ALL THE ACCEPTANCE CRITERIA FOR STERILITY RELEASE. THEREFORE, IT IS HIGHLY UNLIKELY THAT THE SPECIFIED DEVICES CAUSED OR CONTRIBUTED TO ANY PATIENT INFECTION. A DEFINITIVE CAUSE ANALYSIS FOR THE SUBSEQUENT FEMORAL COMPONENT LOOSENING CANNOT BE CONDUCTED WITH THE INFORMATION PROVIDED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS TWO-STAGE REVISION FOR INFECTION ON (B)(6) 2010 AND (B)(6) 2011. HIP STEM WAS LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HG MULTILOCK FEMORAL HIP STEM JDI ZIMMER, INC. 75947700

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LONGEVITY HGP II ACETABULAR LINER:| (B)(4)| CATALOG# 32673208801, LOT# 94001549| LOT# 61530675 MANUFACTURED AT (B)(4)| ZIMMER FEMORAL HEAD: CATALOG# 00902603335