BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN TIVANIUM LPS - FLEX FEMORAL COMPONENT

    MDR report key: 3624731 · Received February 7, 2014

    Report

    Report Number
    1822565-2014-00151
    Event Type
    Injury
    Date Received
    February 7, 2014
    Date of Event
    July 15, 2013
    Report Date
    March 11, 2020
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    PMA / PMN Number
    K173057
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICES OR PHOTOS WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENT IS UNK. 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. REHABILITATION PROTOCOL AND ADHERENCE THERETO IS UNK. COMPATIBILITY WAS REVIEWED WITH NO ISSUES NOTED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFO PROVIDED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECS. 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 ADD'L SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    OTHER DEVICE USED: CATALOG #00598005701, NEXGEN STEMMED TIBIAL COMPONENT, LOT #61783570, MANUFACTURED AT ZIMMER B.V., (B)(4); CATALOG #00111214001, PALACOS R BONE CEMENT, LOT #72384289, THIS BONE CEMENT IS MANUFACTURED AT HERAEUS MEDICAL AND DISTRIBUTED THROUGH ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS. UPDATED INFORMATION RECEIVED VIA OPERATIVE NOTES. REVIEW OF THE PRIMARY OPERATIVE NOTES DOES NOT INDICATE ROOT CAUSE. EXCELLENT RANGE OF MOTION WAS REPORTED WITH STABILITY IN ALL RANGES INCLUDING MID-FLEXION. THE CEMENT WAS ALLOWED TO CURE WITH THE KNEE IN FULL EXTENSION AND EXCESS CEMENT WAS REMOVED. REVIEW OF THE REVISION NOTES INDICATES THE TIBIAL AND FEMORAL COMPONENTS WERE LOOSE AND BOTH WERE EXPLANTED. A DESCRIPTION OF THE CONDITION OF THE EXPLANTS WAS NOT PROVIDED. NO EVIDENCE OF INFLAMMATION OR SYNOVITIS WAS NOTED. ROOT CAUSE REMAINS UNKNOWN.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL EVALUATION OF THE RETURNED DEVICE SHOWS SIGNS OF USE ON THE FEMORAL AND TIBIAL COMPONENTS. BOTH DEVICES HAD BONE CEMENT REMAINING ON THE BACKSIDE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN RISK DOCUMENTATION. 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.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT'S LEFT KNEE WAS REVISED DUE TO PAIN.

    Description of Event or Problem · 1

    FROM ADDITIONAL INFORMATION RECEIVED, IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO PAIN AND LOOSENING OF THE FEMORAL AND TIBIAL TRAY. ALL COMPONENTS WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80021 NEXGEN TIVANIUM LPS - FLEX FEMORAL COMPONENT PROSTHESIS, KNEE JWH ZIMMER, INC. 61724778

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R NEXGEN LPS-FLEX PROLONG ARTICULAR SURFACE:| CAT # 00596205110, LOT #61410089