BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK NEXGEN KNEE

    MDR report key: 3201660 · Received June 28, 2013

    Report

    Report Number
    1822565-2013-01044
    Event Type
    Injury
    Date Received
    June 28, 2013
    Report Date
    May 31, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: IT IS REPORTED THAT THE PT CANNOT OBTAIN FLEXION BEYOND 90 DEGREES WITH A NEXGEN LEGACY IMPLANT. REVISION SURGICAL NOTES HAVE BEEN PROVIDED AND INDICATED THAT THE PT UNDERWENT MANIPULATION AND SYNOVECTOMY DUE TO STIFFNESS AFTER IMPLANT SURGERY. IT IS NOTED THAT THESE PROCEDURES WERE NOT SUCCESSFUL AND THE PT WAS ULTIMATELY REVISED DUE TO STIFFNESS AND PAIN ON (B)(6) 2011. BOTH TIBIAL AND FEMORAL COMPONENTS ARE NOTED TO HAVE BEEN REMOVED BY SAW AND OSTEOTOME INDICATING THEY WERE NOT LOOSE. ALSO, THE REVISION NOTES INDICATE THAT SCAR TISSUE WAS EXCISED AND LIGAMENT/TISSUE RELEASES WERE PERFORMED. X-RAYS WERE NOT PROVIDED; IT IS UNK WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. THERE IS NO INDICATION THAT THE COMPONENTS FAILED. IT IS POSSIBLE THAT THE PT'S ANATOMY AND SCAR TISSUE CONTRIBUTED TO THE LACK OF FLEXION WITH THE IMPLANTS; HOWEVER, THIS CANNOT BE DETERMINED CONCLUSIVELY. THE PART NUMBERS AND LOT NUMBERS ARE UNK; THEREFORE THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. 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 AVAILABLE INFO, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT FOLLOWING A REVISION SURGERY FOR PAIN AND STIFFNESS, THE PT IS CONTINUING TO EXPERIENCE THESE SYMPTOMS. CONCERNS OF A POSSIBLE METAL ALLERGY HAVE ALSO BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297040 UNK NEXGEN KNEE KNEE PROSTHESIS JWH ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other