BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN FLUTED STEM MOBILE TIBIAL COMPONENT

    MDR report key: 3327807 · Received March 12, 2013

    Report

    Report Number
    1822565-2013-00468
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 14, 2013
    Manufacturer
    ZIMMER INC.
    Product Code
    NJL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS BONE CEMENT IS MANUFACTURED AT HERAEUS MEDICAL AND DISTRIBUTED THROUGH ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS. EVAL SUMMARY: FIT AND ORIENTATION COULD NOT BE EVALUATED WITHOUT X-RAYS OR SURGICAL NOTES. PT 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 UNK. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFO PROVIDED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECS. 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 ADD'L SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT WAS REVISED DUE TO INSTABILITY AND TIBIAL COMPONENT LOOSENING. THE FEMORAL COMPONENT WAS INTERNALLY ROTATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104985 NEXGEN FLUTED STEM MOBILE TIBIAL COMPONENT NJL ZIMMER INC. 61756361

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention UNK FEMORAL COMPONENT: LOT UNK, CAT UNK| PALACOS R+G BONE CEMENT: LOT #71764268,| NEXGEN PROLONG LPS-MOBILE ARTICULAR SURFACE:| PALACOS R+G BONE CEMENT: LOT #72604282,| CAT #00111314001| LOT #61835259, CAT #00591707012| CAT #00111314001