BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN CR ARTICULAR SURFACE

    MDR report key: 2780645 · Received October 5, 2012

    Report

    Report Number
    1822565-2012-02047
    Event Type
    Injury
    Date Received
    October 5, 2012
    Report Date
    September 7, 2012
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: NEITHER SURGICAL NOTES NOR X-RAYS WERE PROVIDED, THEREFORE FIT AND ORIENTATION COULD NOT BE EVALUATED. 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 UNKNOWN. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFO PROVIDED. EVAL: 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 ADD¿L SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT WAS REVISED DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN CR ARTICULAR SURFACE JWH ZIMMER, INC. 60576035

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention NEXGEN STEMMED TIBIAL COMPONENT:| CAT#00597206532, LOT# 60721043| THE FOLLOWING DEVICES WERE MANUFACTURED BY| CAT# 00598004702, LOT# 60674842| ZIMMER (B)(4)| NEXGEN ALL POLY PATELLA:| CAT# 00595001606, LOT# 60606542| NEXGEN CR-FLEX FEMORAL COMPONENT: