BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LPS-FLEX GSF FEMORAL COMPONENT

    MDR report key: 4067999 · Received August 12, 2014

    Report

    Report Number
    3007963827-2014-00038
    Event Type
    Injury
    Date Received
    August 12, 2014
    Report Date
    June 21, 2014
    Manufacturer
    ZIMMER ORTHOPEDIC MFG LTD
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: COMPATIBILITY WAS VERIFIED WITH NO ISSUES NOTED. NO DEVICES OR PHOTOS WERE PROVIDED; THEREFORE, THE CONDITION OF THE COMPONENTS IS UNKNOWN. OPERATIVE NOTES WERE NOT PROVIDED. RADIOGRAPHS WERE NOT PROVIDED; IT IS UNKNOWN WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NO INFORMATION HAS BEEN RECEIVED TO DATE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. HOWEVER, THE COMPLAINT MAY BE REVISED UPON RETURN OF RADIOGRAPHS AND/OR PRODUCT OR FURTHER INFORMATION. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE AVAILABLE INFORMATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. THE INFORMATION PROVIDED ON THIS FORM WAS PREVIOUSLY SUBMITTED UNDER MANUFACTURING REPORT NUMBER 1822565-2014-00878.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT IS EXPERIENCING DIFFICULTIES WITH HER TOTAL KNEE REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479328 NEXGEN LPS-FLEX GSF FEMORAL COMPONENT JWH ZIMMER ORTHOPEDIC MFG LTD 62630814

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 00598603701, LOT# 62588902.| #62491396.| (B)(4).| NEXGEN ALL POLY PATELLA, CATALOG# 00597206532, LOT| NEXGEN LPS-FLEX PROLONG ARTICULAR SURFACE, CATALOG| NEXEN OPTION STEMMED TIBIAL COMPONENT, CATALOG#| OTHER DEVICES USED: ALL MANUFACTURED BY ZIMMER| #00596203210, LOT# 62411654.