BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN NEXGEN CR-FLEX FEMORALCOMPONENT

    MDR report key: 3591306 · Received January 15, 2014

    Report

    Report Number
    1822565-2014-00075
    Event Type
    Injury
    Date Received
    January 15, 2014
    Date of Event
    February 18, 2013
    Report Date
    March 9, 2020
    Manufacturer
    ZIMMER INC.
    Product Code
    JWH
    PMA / PMN Number
    K173057
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SURGICAL NOTES WERE NOT PROVIDED. X-RAYS WERE NOT PROVIDED; IT IS UNKNOWN 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 INFORMATION PROVIDED. EVALUATION CODES: REVIEW OF THE DEVICE HISTORY RECORDS FOR THE FEMORAL COMPONENT WERE REVIEWED, INDICATING THE DEVICE WAS MANUFACTURED, INSPECTED, AND PACKAGED TO 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 ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL EVALUATION OF THE RETURNED DEVICE SHOWS NICKS AND GOUGES ON THE DEVICES AND BONE CEMENT REMAINED ON THE FEMORAL AND TIBIAL COMPONENT. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN RISK DOCUMENTATION.  ROOT CAUSE REMAINS UNCHANGED FROM PREVIOUS INVESTIGATION. 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 Manufacturer Narrative · 1

    OTHER DEVICES USED: CATALOG #00598003702, NEXGEN STEMMED TIBIAL COMPONENT, LOT #61172966; MANUFACTURED AT ZIMMER B.V., (B)(4). CATALOG #00111314001, PALACOS R+G BONE CEMENT, LOT #67764200; THIS BONE CEMENT IS MANUFACTURED AT HERAEUS MEDICAL AND DISTRIBUTED THROUGH ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS. UPDATED INFORMATION RECEIVED VIA OPERATIVE NOTES. PRIMARY OPERATIVE NOTES INDICATE FULL EXTENSION AND 135 DEGREES OF FLEXION WERE ACHIEVED WITHOUT ANY INSTABILITY TO VARUS/VALGUS OR ANTERIOR/POSTERIOR STRESSES. THE CEMENT WAS ALLOWED TO CURE WITH THE KNEE IN FULL EXTENSION AND EXCESS CEMENT WAS REMOVED. REVIEW OF THE PRIMARY OPERATIVE NOTES DOES NOT INDICATE ROOT CAUSE. REVISION OPERATIVE NOTES CONFIRM THE FEMORAL COMPONENT WAS GROSSLY LOOSE. THE TIBIAL COMPONENT WAS REPORTED TO BE QUESTIONABLY LOOSE AND WAS REMOVED FAIRLY EASILY. A FROZEN SECTION WAS NEGATIVE FOR ACUTE INFECTION. ROOT CAUSE REMAINS UNKNOWN AT THIS TIME.

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

    FROM ADDITIONAL INFORMATION, IT WAS REPORTED IN MEDICAL RECORDS THAT THE PATIENT WAS INDICATED WITH INSTABILITY AND LOOSENING OF FEMORAL PROSTHESIS. FURTHER, THE TIBIAL COMPONENT WAS QUESTIONABLY LOOSE AND WAS REMOVED FAIRLY EASILY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39689 UNKNOWN NEXGEN CR-FLEX FEMORALCOMPONENT PROSTHESIS, KNEE JWH ZIMMER INC. 61124915

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R