BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN COMPLETE KNEE SOLUTION STEMMED TIBIAL COMPONENT PRECOAT

    MDR report key: 1241107 · Received November 21, 2008

    Report

    Report Number
    1822565-2008-00833
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    October 17, 2008
    Report Date
    October 17, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY - NO PRODUCT WAS RETURNED FOR REVIEW. ALSO, X-RAYS WERE NOT RETURNED AS WELL. THE CAUSE OF THE TIBIAL COMPONENT LOOSENING AND WEAR OF THE ARTICULAR SURFACE CANNOT BE DEFINITELY DETERMINED DUE TO INSUFFICIENT INFORMATION. NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS FOR ITEM NUMBER DID NOT FIND ANY DEVIATIONS OR ANOMALIES. REVIEW OF THE DEVICE HISTORY RECORDS WAS ALSO NO POSSIBLE FOR THE UNKNOWN ARTICULAR SURFACE 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. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT INITIAL KNEE REPLACEMENT SURGERY WAS PERFORMED IN 2005, AND THAT THE PATIENT WAS REVISED IN 2008, DUE TO LOOSENING OF THE TIBIAL COMPONENT AND PAIN EXPRESSED BY THE PATIENT. WHEN REVISION WAS PERFORMED, PREMATURE WERE ON THE POLY WAS FOUND AND THERE WAS OSTEOLYSIS UNDER THE MEDIAL SIDE OF THE TIBIAL COMPONENT AND THE LATERAL SIDE OF THE FEMORAL COMPONENT. NUMEROUS CULTURES WERE TAKEN. THE SURGEON CREATED AN ANTIBIOTIC SPACER MADE FROM BONE CEMENT AND INSERTED INTO THE JOINT SPACE. THE SURGEON IS WAITING ON CULTURE RESULTS AFTER 5 DAYS IN THE LAB TO FIND OUT IF THE PATIENT IS INFECTED TO EXPLAIN THE EARLY POLY WEAR AND OSTEOLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN COMPLETE KNEE SOLUTION STEMMED TIBIAL COMPONENT PRECOAT KNEE PROSTHESES HSH ZIMMER, INC. NA 60307177

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R SURFACE: CATALOG# UNK| UNKNOWN ZIMMER NEXGEN COMPLETE KNEE SOLUTION| LEGACY KNEE POSTERIOR STABILIZED (LPS) ARTICULAR