BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN STEMMED TIBIAL COMPONENT

    MDR report key: 2890765 · Received December 21, 2012

    Report

    Report Number
    2648920-2012-00273
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    November 28, 2012
    Report Date
    November 30, 2012
    Manufacturer
    ZIMMER
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: ONE PHOTOGRAPH OF THE TIBIAL PLATE IN A PLASTIC BAG WAS RECEIVED; NO ADHERING CEMENT IS OBSERVED. FIT AND ORIENTATION COULD NOT BE EVALUATED WITHOUT X-RAYS OR SURGICAL NOTES. PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, ACTIVITY LEVEL OR TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT) ARE UNKNOWN. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. MANUFACTURING DOCUMENTATION FOR THE TIBIAL PLATE WAS REVIEWED AND INDICATES THAT THE DEVICE WAS MANUFACTURED, INSPECTED, AND PACKAGED TO SPECIFICATION. THE LOT NUMBER OF THE BONE CEMENT IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORDS FOR THE BONE CEMENT COULD NOT BE REVIEWED. 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.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT WAS REVISED DUE TO THE TIBIAL IMPLANT SUBSIDENCE. NO CEMENT WAS FOUND TO BE ADHERED TO THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN STEMMED TIBIAL COMPONENT JWH ZIMMER 60683515

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention PALACO R+G BONE CEMENT: CATALOG #00111314001| (B)(4)| AND DISTRIBUTED THROUGH (B)(4)| LOT #UNK| THS BONE CEMENT IS MANUFACTURED AT HERAEUS MEDICAL