BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN ZIMMER NEXGEN KNEE

    MDR report key: 1070982 · Received July 3, 2008

    Report

    Report Number
    1822565-2008-00392
    Event Type
    Malfunction
    Date Received
    July 3, 2008
    Date of Event
    May 22, 2008
    Report Date
    June 4, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PT HAD A REVISION TKA PERFORMED FIVE YEARS AGO AND THE X-RAYS SHOW THE BONE LOSS ON THE PROXIMAL TIBIA ON THE MEDIAL SIDE. THE TIBIA SHOWS SIGNIFICANT BONE LOSS. THE PT HAS A MEDIUM BUILD AND MEDIUM ACTIVITY LEVEL. DEVICES ARE STILL IMPLANTED AND NOT AVAILABLE FOR REVIEW. ITEM NUMBER AND LOT NUMBER OF THE TIBIAL COMPONENT IS NOT KNOWN. THE CAUSE OF THE PROBLEM COULD NOT BE DEFINITIVELY DETERMINED, HOWEVER, THERE IS A CONSIDERABLE BONE LOSS/DAMAGE TO TIBIA AND IT APPEARS TO BE FROM THE PREVIOUS IMPLANT. NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS WAS ALSO 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. BASED ON THE AVAILABLE INFORMATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE DEVICE WAS IMPLANTED IN EARLY 2003. POST-OP VISIT IN 2008, X-RAYS SHOW PATIENT IS EXPERIENCING BONE LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN ZIMMER NEXGEN KNEE KNEE PROSTHESIS JWH ZIMMER, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR