BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER NATURAL-KNEE II SYSTEM STEMMED TIBIAL BASEPLATE SIZE 4, LEFT, POROUS COAT

    MDR report key: 2821136 · Received November 1, 2012

    Report

    Report Number
    MW5027460
    Event Type
    Injury
    Date Received
    November 1, 2012
    Date of Event
    November 3, 2010
    Report Date
    October 25, 2012
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT PREVIOUSLY HAD LEFT PARTIAL KNEE REPLACEMENT, WHICH HAD PROVEN INSUFFICIENT TO CORRECT JOINT PROBLEMS. PATIENT HAD LEFT TOTAL KNEE REPLACEMENT (TKR) ON (B)(6) 2010 USING ZIMMER NATURAL KNEE SYSTEM PRODUCTS. SEVERE CHRONIC PAIN AND MOBILITY ISSUES PERSISTED. THE TIBIAL COMPONENT OF THE TKR PROVED FAULTY, FAILED, AND NECESSITATED A REVISION SURGERY WITHIN SIX MONTHS. BEGINNING ON (B)(6) 2011 (12 WEEKS AFTER SURGERY) X-RAYS BEGAN TO SHOW LOOSENING OF THE TIBIAL COMPONENT, WHICH CONTINUED TO WORSEN UNTIL A REVISION OF THE TKR WAS NECESSARY. THE REVISION SURGERY TOOK PLACE ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER NATURAL-KNEE II SYSTEM STEMMED TIBIAL BASEPLATE SIZE 4, LEFT, POROUS COAT ARTIFICIAL KNEE COMPONENT HSH ZIMMER, INC. 61428572

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention