BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LEGACY KNEE LPS ARTICULAR SURFACE

    MDR report key: 2030632 · Received March 18, 2011

    Report

    Report Number
    1822565-2011-00657
    Event Type
    Injury
    Date Received
    March 18, 2011
    Date of Event
    October 30, 2008
    Report Date
    September 24, 2009
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION 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 LOTS SPECIFIED IN THIS COMPLAINT WERE PROCESSED ACCORDING TO THE VALIDATED STERILIZATION PROCESS PARAMETERS AND MET ALL THE ACCEPTANCE CRITERIA FOR STERILITY RELEASE. IN ADDITION, BEFORE EACH LOT IS RELEASED, THE "CERTIFICATE OF PROCESSING" FROM THE STERILIZATION SUPPLIER IS REVIEWED FOR CONFORMANCE. THIS CERTIFICATE LISTS THE MAXIMUM, MINIMUM AND ACTUAL GAMMA DOSE IN KGY. THEREFORE, IT IS HIGHLY UNLIKELY THAT THE SPECIFIED DEVICE CAUSED OR CONTRIBUTED TO ANY PATIENT INFECTION. EVALUATION: 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. THIS MDR WAS IDENTIFIED DURING AN INTERNAL REVIEW TO MEET REPORTING REQUIREMENTS AND THEREFORE IS BEING FILED LATE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT WAS REVISED FOR INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN LEGACY KNEE LPS ARTICULAR SURFACE JWH ZIMMER, INC. 60055395

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention CATALOG #00599601501, LOT# 07875487| CATALOG #00597206529, LOT#60125796, MANUFACTURED| NEXGEN COMPLETE KNEE SOLUTION ALL POLY PATELLA| POSTERIOR STABILIZED (LPS) FEMORAL COMPONENT| NEXGEN COMPLETE KNEE SOLUTION LEGACY KNEE-| AT ZIMMER BV, PONCE, PUERTO RICO| NEX GEN COMPLETE KNEE SOLUTION STEMMED TIBIAL| COMPONENT: CATALOG #00598004701, LOT #60127454