BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN MIS STEMMED TIBIAL COMPONENT

    MDR report key: 1910994 · Received November 23, 2010

    Report

    Report Number
    1822565-2010-01173
    Event Type
    Injury
    Date Received
    November 23, 2010
    Date of Event
    September 27, 2010
    Report Date
    October 19, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE STERILIZATION PROCESSES FOR THESE DEVICES WERE 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. CAUSE OF INFECTION CANNOT BE DETERMINED. EVALUATION: NO PRODUCT WAS RETURNED. 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 RE-OPENED. ZIMMER, INC CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT WAS REVISED DUE TO A POSSIBLE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN MIS STEMMED TIBIAL COMPONENT KNEE PROSTHESIS JWH ZIMMER, INC. 60955228

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention CATALOG #00597206538, LOT #60791293| CATALOG #00576401452, LOT #60909276| NEXGEN LPS-FLEX GSF FEMORAL COMPONENT| MANUFACTURED BY ZIMMER - (B)(4)| CATALOG #00596203010, LOT #60852960| NEXGEN LPS-FLEX PROLONG HIGHLY CROSSLINKED POLY| ARTICULAR SURFACE| NEXGEN ALL POLY PATELLA: