BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATURAL KNEE II CONGRUENT TIBIAL INSERT

    MDR report key: 1821496 · Received August 25, 2010

    Report

    Report Number
    1822565-2010-00609
    Event Type
    Injury
    Date Received
    August 25, 2010
    Date of Event
    July 20, 2010
    Report Date
    July 27, 2010
    Manufacturer
    ZIMMER INC.
    Product Code
    JWH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 AND THE DATE OF THE ORIGINAL IMPLANTATION SUGGEST 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. THE IMPLANTATION DATE IS PRIOR TO THE CORRECTIVE ACTION. NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS FOR THE INSERT DID NOT FIND ANY DEVIATIONS OR ANOMALIES. REVIEW OF THE DEVICE HISTORY RECORDS OR THE BASEPLATE WAS NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. 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 IS PRESENTING WITH STAGE 4 OSTEOLYSIS AND A STRESS FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NATURAL KNEE II CONGRUENT TIBIAL INSERT KNEE PROSTHESIS JWH ZIMMER INC. 1328684

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other CATALOG # 621201230| NATURAL KNEE II SYSTEM STEMMED TIBIAL BASEPLATE| LOT # UNK