BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN KNEE STEMMED NONAUGMENTABLE TIBIA

    MDR report key: 2100546 · Received May 17, 2011

    Report

    Report Number
    1822565-2011-01199
    Event Type
    Injury
    Date Received
    May 17, 2011
    Date of Event
    March 30, 2011
    Report Date
    April 18, 2011
    Manufacturer
    ZIMMER
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVAL SUMMARY: THE ARTICULAR SURFACE EXHIBITS SIGNIFICANT PITTING ON THE CONDYLES. THE INFERIOR SURFACE EXHIBITS BACKSIDE WEAR CONSISTENT WITH THE PRESENCE OF A THIRD BODY. THE TIBIAL PLATE SHOWS SCRATCHING ON BOTH THE SUPERIOR AND INFERIOR SURFACES. THE ROTATIONAL PATTERN OF SCRATCHES ON SUPERIOR SURFACE SUGGESTS THAT A THIRD BODY WAS PRESENT BETWEEN THE TIBIAL PLATE AND THE ARTICULAR SURFACE RESULTING IN WEAR. SOME SCRATCHES ON THE INFERIOR SURFACE APPEAR TO EXHIBIT SMALL ANGLE ROTATIONS WHICH IS CONSISTENT WITH THE REPORT THAT THE COMPONENT WAS NOT WELL-FIXED IN CEMENT. NO BONE CEMENT RESIDUE APPEARS ON THE INFERIOR SURFACE OF THE PLATE. TIBIAL PLATE LOOSENING CAN BE INFLUENCED BY MULTIPLE FACTORS INCLUDING, BUT NOT LIMITED TO, PT ANATOMY, WEIGHT, ACTIVITY, BONE QUALITY, IMPLANT SIZE, SURGICAL TECHNIQUE, AND REHABILITATION PROGRAM. THEREFORE, WITHOUT FURTHER INFO, A DEFINITE CAUSE CANNOT BE DETERMINED AT THIS TIME. EVAL: DIMENSIONS TAKEN ARE WITHIN SPEC. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE TIBIAL COMPONENT WAS IMPLANTED IN 2004, PT WAS REVISED DUE TO LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN KNEE STEMMED NONAUGMENTABLE TIBIA JWH ZIMMER 60151307

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention NEXGEN COMPLETE KNEE LPS ARTICULAR SURFACE:| CATALOG #00599605012, LOT #60167503| MANUFACTURE ZIMMER (B)(4)