BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LEGACY LCCK FEMORAL COMPONENT

    MDR report key: 1924227 · Received December 7, 2010

    Report

    Report Number
    1822565-2010-01267
    Event Type
    Injury
    Date Received
    December 7, 2010
    Date of Event
    August 4, 2010
    Report Date
    November 10, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A HEALTH PROFESSIONAL WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. 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 MANUFACTURING LOT SPECIFIED IN THIS COMPLAINT WAS PROCESSED ACCORDING TO THE VALIDATED STERILIZATION PROCESS PARAMETERS AND MET ALL ACCEPTANCE CRITERIA FOR STERILITY RELEASE. THEREFORE, IT IS HIGHLY UNLIKELY THAT THE SPECIFIED DEVICE CAUSED OR CONTRIBUTED TO ANY PT INFECTION. EVALUATION CODES: 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.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT WAS REVISED DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN LEGACY LCCK FEMORAL COMPONENT KNEE PROSTHESIS HSA ZIMMER, INC. 61236355

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention CATALOG #00598802113| LOT #60770634| CATAGLOG #00599405020| NEXGEN STEMMED TIBIAL COMPONENT| LOT #60401921| NEXGEN LEGACY LCCK ARTICULAR SURFACE| MANUFACTURED BY ZIMMER B.V. (B)(4)| LOT #61252020| NEXGEN STEM EXTENSION OFFSET| CATALOG #00598801018| CATALOG #00598800700| NEXGEN STEM EXTENTSION| LOT #61044659