BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN COMPLETE STEMMED TIBIAL COMPONENT

    MDR report key: 1970887 · Received January 4, 2011

    Report

    Report Number
    1822565-2011-00006
    Event Type
    Malfunction
    Date Received
    January 4, 2011
    Report Date
    December 7, 2010
    Manufacturer
    ZIMMER INC.
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: SURGICAL NOTES WERE NOT PROVIDED. X-RAYS WERE NOT PROVIDED; IT IS UNK WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFO PROVIDED. H6: EVAL: REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. 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 AVAILABLE INFO, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL 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 IS PRESENTING WITH PAIN AND CLICKING IN HER RIGHT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN COMPLETE STEMMED TIBIAL COMPONENT KNEE PROSTHESIS JWH ZIMMER INC. 61202218

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR NEXGEN CR ARTICULAR SURFACE| NEXGEN CR-FLEX GSF FEMORAL COMPONENT| CATALOG# 00575001602, LOT# 61189628| CATALOG# 90597004010, LOT# 61210549| NEXGEN ALL POLY PATELLA| CATALOG# 00597206532, LOT# 61222145| MANUFACTURED BY ZIMMER BV - (B)(4)