BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATURAL-KNEE II TIBIAL INSERT

    MDR report key: 2092633 · Received May 10, 2011

    Report

    Report Number
    1822565-2011-01140
    Event Type
    Injury
    Date Received
    May 10, 2011
    Date of Event
    February 23, 2011
    Report Date
    April 12, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A FOREIGN SOURCE WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVALUATION SUMMARY: NO PRODUCT OR X-RAYS WERE RETURNED FOR REVIEW. WHILE A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED, THE COMMON CLINICAL PRESENTATION SUGGESTS THAT THE EVENT IS RELATED TO THE ISSUES FOR WHICH ZIMMER IMPLEMENTED A CORRECTION ACTION FOR IN 2007. THIS CORRECTIVE ACTION INVOLVED ENHANCING THE LABELING FOR THE NATURAL KNEE II KNEE SYSTEM. REFERENCE MDR 1822565-2006-00284 FOR ADDITIONAL INFORMATION REGARDING THE CORRECTIVE ACTION TAKEN. EVALUATION: 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. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT WAS REVISED FOR RADIOGRAPHICALLY PROVEN OSTEOLYTIC LESIONS AT THE TIBIA HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NATURAL-KNEE II TIBIAL INSERT KNEE PROSTHESIS HSH ZIMMER, INC. 1591927

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention TIBIAL BASEPLATE: CATALOG #621200220, LOT #1592971| NATURAL-KNEE II SYSTEM POROUS COATED STEMMED