BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN MIS STEMMED TIBIAL COMPONENT

    MDR report key: 2792342 · Received October 12, 2012

    Report

    Report Number
    1822565-2012-02084
    Event Type
    Injury
    Date Received
    October 12, 2012
    Report Date
    September 13, 2012
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NEITHER X-RAYS NOR SURGICAL NOTES WERE RETURNED. COMPONENT FIT AND ORIENTATION IS UNKNOWN. PATIENT MEDICAL HISTORY IS UNKNOWN, AS IS REHABILITATION PROTOCOL AND ADHERENCE THERETO. IT IS UNKNOWN IF THE PATIENT EXPERIENCED ANY UNREPORTED TRAUMATIC EVENT. WITH THE INFORMATION PROVIDED, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. 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 WAS REPORTED THAT THE PATIENT IS EXPERIENCING KNEE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN MIS STEMMED TIBIAL COMPONENT JWH ZIMMER, INC. 60692582

    Patients

    Seq Age Sex Outcome Treatment
    1 Other NEXGEN LPS FEMORAL COMPONENT, CATALOG #00599201501| LOT #60766426| #00596204014, LOT #60801939| NEXGEN ALL POLY PATELLA, CATALOG #00597206535, LOT| #60674972, MANUFACTURED AT ZIMMER| (B)(4)| NEXGEN LPS-FLEX PROLONG ARTICULAR SURFACE, CATALOG