BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN CRUCIATE RETAINING ARTICULAR SURFACE

    MDR report key: 1960954 · Received January 11, 2011

    Report

    Report Number
    1822565-2011-00058
    Event Type
    Injury
    Date Received
    January 11, 2011
    Report Date
    December 14, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A CONSUMER WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT UNDERWENT AN ADD'L PROCEDURE TO REMOVE SCAR TISSUE. THE LOSS OF RANGE OF MOTION IS ALSO REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN CRUCIATE RETAINING ARTICULAR SURFACE KNEE PROSTHESIS JWH ZIMMER, INC. 60493134

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention NEXGEN MIS STEMMED TIBIAL COMPONENT| NEXGEN ALL POLY PATELLA, CATALOG# 005972206538| CATALOG# 00595005701, LOT# 60467851| LOT# 60469488| CATALOG# 00595001702, LOT# 60432412| NEXGEN CR-FLEX FEMORAL COMPONENT| (B)(4)