BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN STEMMED PRECOAT TIBIAL PLATE

    MDR report key: 4252935 · Received November 12, 2014

    Report

    Report Number
    2648920-2014-00310
    Event Type
    Injury
    Date Received
    November 12, 2014
    Date of Event
    April 3, 2013
    Report Date
    April 18, 2014
    Manufacturer
    ZIMMER
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE PRIMARY OPERATIVE NOTES DOES NOT INDICATE ROOT CAUSE. REVISION OPERATIVE NOTES CONFIRM THE PATIENT UNDERWENT A REVISION LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2013 DUE TO A FAILED LEFT TOTAL KNEE SECONDARY TO RECURRENT FALLS. THE PATELLAR COMPONENT WAS FOUND TO BE STABLE. THE TIBIAL COMPONENT WAS FOUND TO HAVE A SETTLED SLIGHTLY INTO THE LATERAL PLATEAU. A POWER SAW AND OSTEOTOME WERE UTILIZED TO LOOSEN AND REMOVE THE FEMORAL AND TIBIAL COMPONENTS. NO FURTHER DESCRIPTION OF THE COMPONENTS WAS PROVIDED. IT IS LIKELY THAT THE RECURRENT FALLS EXPERIENCED BY THE PT CONTRIBUTED TO THE REPORTED ISSUE. DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. 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 AVAILABLE INFO, 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. THE INFO PROVIDED ON THIS FORM WAS PREVIOUSLY SUBMITTED UNDER MANUFACTURING REPORT NUMBER 1822565-2014-00622.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT WAS REVISED DUE TO IMPLANT FAILURE SECONDARY TO RECURRENT FALLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729806 NEXGEN STEMMED PRECOAT TIBIAL PLATE JWH ZIMMER 60961593

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention