BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LPS-FLEX FEMORAL COMPONENT

    MDR report key: 5565762 · Received April 9, 2016

    Report

    Report Number
    1822565-2016-01008
    Event Type
    Injury
    Date Received
    April 9, 2016
    Date of Event
    October 22, 2013
    Report Date
    April 21, 2017
    Manufacturer
    ZIMMER INC
    Product Code
    JWH
    PMA / PMN Number
    PK060370
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL PRODUCT: ZIMMER NEXGEN LPS-FLEX GSF FEMORAL COMPONENT OPTION (CATALOG# 00-5764-014-51, LOT# 60955477), ZIMMER NEXGEN FLUTED STEMMED TIBIAL COMPONENT (CATALOG# 00-5996-028-01, LOT# 60582732), ZIMMER NEXGEN LPS-FLEX ARTICULAR SURFACE (CATALOG# 00-5962-022-10, LOT# 60970453), ZIMMER NEXGEN ALL POLY PATELLA (CATALOG# 00-5972-065-29, LOT# 60997235), ZIMMER PALACOS R RADIOPAQUE BONE CEMENT (CATALOG# 00-1112-140-01, LOT# 68834190) THERAPY DATE: (B)(6) 2013. RECORDS RECEIVED STATE THE PATIENT UNDERWENT LEFT KNEE REVISION INSTABILITY DUE TO CONNECTIVE TISSUE LAXITY DISORDER AFTER ABOUT 5 YEARS FROM PRIMARY TKA AT 2008. PATIENT HAD OBVIOUS SYSTEMIC CONNECTIVE TISSUE DISORDER WITH LIGAMENTOUS LAXITY AND HYPEREXTENSION. THE PRIMARY SURGICAL NOTES STATE THAT THE PATIENT UNDERWENT TKA TO TREAT LEFT KNEE OSTEOARTHRITIS. TRIAL TIBIAL AND FEMORAL COMPONENTS WERE PLACED AND THE KNEE WAS TAKEN THROUGH RANGE OF MOTION. THE PATIENT'S RANGE OF MOTION, STABILITY AND SOFT TISSUE BALANCING WERE ASSESSED AND ALL WERE SATISFACTORY. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO ANOMALIES OR DEVIATIONS WERE IDENTIFIED THAT WOULD IMPACT THE REPORTED EVENT. A COMPLAINT HISTORY REVIEW REVEALED NO ADDITIONAL COMPLAINTS AGAINST THE RELATED PART AND LOT NUMBER COMBINATIONS. NEXGEN KNEE SYSTEM PACKAGING INSERT, STATE JOINT INSTABILITY AND PAIN AS POSSIBLE ADVERSE EFFECTS, AND IS THEREFORE A KNOWN RISK OF THIS PROCEDURE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. ADDITIONAL MDR REPORTS WERE FILED FOR THIS EVENT; PLEASE SEE ASSOCIATED REPORT: 0001822565-2017-02196.

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. (B)(4). THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221043 NEXGEN LPS-FLEX FEMORAL COMPONENT JWH JWH ZIMMER INC N/A 60955477

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention