BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN COMPLETE KNEE SOLUTION STEM EXTENSION OFFSET

    MDR report key: 1241114 · Received November 21, 2008

    Report

    Report Number
    1822565-2008-00827
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    October 15, 2008
    Report Date
    October 17, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    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 OF 10-6 OR BETTER. THE MANUFACTURING LOT SPECIFIED IN THIS COMPLAINT WAS PROCESSED ACCORDING TO THE VALIDATED STERILIZATION PROCESS PARAMETERS AND MET ALL OF THE ACCEPTANCE CRITERIA FOR STERILITY RELEASE. IT HAS BEEN DETERMINED THROUGH THIS INVESTIGATION THAT THE DEVICE SPECIFIED IN THIS COMPLAINT MET THE STERILITY ASSURANCE REQUIREMENTS OF THE FDA REGULATIONS AND ISO STANDARDS. THEREFORE, IT IS UNLIKELY THAT THE SPECIFIED DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT INFECTION. DEVICE HISTORY RECORDS INDICATE ALL COMPONENTS WERE MANUFACTURED AND INSPECTED TO SPECIFICATION.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE DEVICE WAS IMPLANTED IN 2008 AND EXPLANTED ON TWO MONTHS LATER. A THA WAS PERFORMED ON THE SAME SIDE LEG ON THE SAME DAY. THE KNEE WOUND NEVER HEALED, AND AT TIME OF REVISION, KNEE IMPLANTS COULD STILL BE CLEARLY SEEN THROUGH INCISION. ALL KNEE IMPLANTS, INCLUDING A DISTAL FEMORAL LOCKING PLATE, WERE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN COMPLETE KNEE SOLUTION STEM EXTENSION OFFSET KNEE PROSTHESIS JWH ZIMMER, INC. NA 60866678

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R SURFACE WITH LOCKING SCREW: CATALOG# 00599403012| ZIMMER PERIATRICULAR LOCKING PLATE SYSTEM DISTAL| PUERTO RICO| OFFSET: CATALOG# 00598802015| MANUFACTURING PONCE| NEXGEN COMPLETE KNEE SOLUTION ALL POLY PATELLA| LOT# 60767174| LOT# 60781430| TIBIAL BASEPLATE: CATALOG# 00598003701| NEXGEN COMPLETE KNEE SOLUTION STEMMED PRECOAT| CATALOG# 00599401492| CONSTRAINED CONDYLAR (LCCK) FEMORAL COMPONENT:| NEXGEN COMPLETE KNEE SOLUTION LEGACY KNEE-| NEXGEN COMPLETE KNEE SOLUTION STEM EXTENSION| LOT# 60968304 MANUFACTURED AT ZIMMER B.V.| MANUFACTURED ZIMMER B.V. MANUFACTURING PONCE| CATALOG# 00597206529| LATERAL FEMORAL PLATE: CATALOG# 00235710206| NEXGEN COMPLETE KNEE SOLUTION LEGACY KNEE-| CONSTRAINED CONDYLAR KNEE (LCCK) ARTICULAR