BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN STEMMED OPTION TIBIAL COMPONENT

    MDR report key: 4934635 · Received July 21, 2015

    Report

    Report Number
    2648920-2015-00261
    Event Type
    Injury
    Date Received
    July 21, 2015
    Date of Event
    June 3, 2015
    Report Date
    June 22, 2015
    Manufacturer
    ZIMMER
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT IDENTIFY ANY DEVIATIONS OR ANOMALIES. A PRODUCT HISTORY SEARCH IDENTIFIED NO OTHER COMPLAINTS FOR THE PART AND LOT COMBINATIONS OF THE ARTICULAR SURFACE OR TIBIAL COMPONENT. INSPECTION OF THE RETURNED ARTICULAR SURFACE IDENTIFIED PITTING AND BACKSIDE WEAR. MEASURED DIMENSIONS FOR BOTH COMPONENTS WERE CONFORMING TO PRINT SPECIFICATIONS. SURGICAL NOTES WERE NOT PROVIDED; IT IS UNKNOWN WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. FROM THE RETURNED X-RAYS, IT APPEARS THAT THE TIBIAL COMPONENT HAS SUBSIDED POSTERIORLY, PRR THE NEXGEN CR, PS, CTA, LPS, AND LCCK KNEE PCK INSERT, LOOSENING OR FRACTURE/DAMAGE OF THE PROSTHETIC KNEE COMPONENTS OR SURROUNDING TISSUES IS A KNOWN RISK OF THIS PROCEDURE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN, OSTEOLYSIS AND LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470798 NEXGEN STEMMED OPTION TIBIAL COMPONENT JWH ZIMMER 61405459

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention MFR. BY ZIMMER INC., (B)(4)| CATALOG#00599604010,| NEXGEN LPS ARTICULAR SURFACE,| LOT #61537910,