BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATURAL KNEE II ARTICULAR SURFACE

    MDR report key: 4212950 · Received October 24, 2014

    Report

    Report Number
    1822565-2014-01449
    Event Type
    Injury
    Date Received
    October 24, 2014
    Report Date
    September 26, 2014
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE PRIMARY OPERATIVE NOTES DOES NOT INDICATE ROOT CAUSE. REVISION OPERATIVE NOTES STATE "OVERTIME SHE HAS STRETCHED OUT TO A SIGNIFICANT RECURVATUM". THE FEMORAL COMPONENT WAS DESCRIBED AS "NOT BADLY SCRATCHED". AN ARTICULAR SURFACE EXCHANGE WAS PERFORMED, REPLACING AN 11 MILLIMETER ARTICULAR SURFACE WITH THE 22 MILLIMETER ARTICULAR SURFACE. THE PATELLAR COMPONENT WAS REMOVED AND THE NEW PATELLAR COMPONENT WAS CEMENTED IN PLACE. THE PATELLAR IMPLANT WAS HELD UNTIL THE CEMENT HARDENED. RADIOGRAPHS WERE NOT PROVIDED; IT IS UNK WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. CAUSE CANNOT BE DEFINITIVELY DETERMINED. EVAL: 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.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT IS EXPERIENCING PAIN, LIMITED MOBILITY, AND A LEG LENGTH DISCREPANCY OF A HALF AN INCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678050 NATURAL KNEE II ARTICULAR SURFACE JWH ZIMMER, INC. 61418712

    Patients

    Seq Age Sex Outcome Treatment
    1 Other NKII POLY PATELLA, CATALOG# 630007101, LOT #| LOT #60346315| NKII FEMORAL COMPONENT, CATALOG# 621200020,| NKII STEMMED TIBIAL COMPONENT, CATALOG #| 62640670| 630700210, LOT # 60377108