BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATURAL-KNEE II SYSTEM TIBIAL INSERT

    MDR report key: 1930682 · Received December 14, 2010

    Report

    Report Number
    1822565-2010-01357
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    November 2, 2010
    Report Date
    November 26, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A FOREIGN SOURCE WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVAL SUMMARY: NO PRODUCT OR X-RAYS WERE RETURNED FOR REVIEW. WHILE A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFO 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 SYS. REFERENCE MDR 1822565-2006-00284 FOR ADDITIONAL INFO REGARDING THE CORRECTIVE ACTION TAKEN. EVAL: 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 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 WAS REVISED FOR RADIOGRAPHICALLY PROVEN OSTEOLYTIC LESIONS AT TIBIA HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NATURAL-KNEE II SYSTEM TIBIAL INSERT KNEE PROSTHESIS HSH ZIMMER, INC. 60307374

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention TIBIAL BASEPLATE, CATALOG #621201220, LOT# 1656536| NATURAL-KNEE II SYSTEM POROUS COATED STEMMED