BEUDAMED
    FDA Adverse Event Other Summary report: N

    NEXGEN COMPLETE KNEE SOLUTION CRUCIATE RETAINING (CR) FEMORAL COMPONENT PRECOAT

    MDR report key: 1534737 · Received November 18, 2009

    Report

    Report Number
    1822565-2009-01148
    Event Type
    Other
    Date Received
    November 18, 2009
    Date of Event
    October 14, 2009
    Report Date
    November 2, 2009
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: AT THIS POINT, NO PRODUCT DEFICIENCY HAS BEEN ALLEGED. CLINICAL EXPERIENCE HAS SHOWN THAT PTS WHO HAVE TESTED POSITIVE FOR METAL SENSITIVITY GENERALLY DO NOT EXHIBIT A REACTION WHEN THE SENSITIZING MATERIAL IS IMPLANTED AS AN ORTHOPAEDIC DEVICE. HOWEVER, IF THIS PT ELICITS AN ALLERGIC OR SENSITIZATION RESPONSE, THIS COMPLAINT MAY BE REVISITED. EVALUATION CODES: NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. 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 INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT HAS A NICKLE ALLERGY OF WHICH THE SALES REP WAS NOT NOTIFIED UNTIL IMPLANTS WERE OPEN AND CEMENT WAS MIXING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN COMPLETE KNEE SOLUTION CRUCIATE RETAINING (CR) FEMORAL COMPONENT PRECOAT KNEE PROSTHESIS HSA ZIMMER, INC. NA 61262436

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK