BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN STEMMED MIS TIBIAL COMPONENT

    MDR report key: 5160147 · Received October 19, 2015

    Report

    Report Number
    1822565-2015-02199
    Event Type
    Injury
    Date Received
    October 19, 2015
    Date of Event
    January 19, 2011
    Report Date
    April 5, 2017
    Manufacturer
    ZIMMER INC
    Product Code
    JWH
    PMA / PMN Number
    PK043101
    Removal / Correction Number
    Z-2413-2010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICES OR PHOTOS WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNKNOWN. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DEVIATIONS OR ANOMALIES WERE IDENTIFIED. THESE DEVICES ARE USED FOR TREATMENT. SURGICAL NOTES WERE NOT PROVIDED; IT IS UNKNOWN WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. WHILE A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED, THE COMMON CLINICAL PRESENTATION AND THE DATE OF THE ORIGINAL IMPLANTATION SUGGEST THAT THE REVISION SURGERY MAY BE RELATED TO THE ISSUES FOR WHICH ZIMMER IMPLEMENTED A CORRECTIVE ACTION IN (B)(4) 2010. A FIELD ACTION WAS CONDUCTED ON APRIL 19, 2010 (SEE NUMBER ABOVE), IN WHICH ZIMMER STRONGLY RECOMMENDS THE USE OF A DROP DOWN STEM EXTENSION IN CONJUNCTION WITH THE BASEPLATE AND CONFIRMING THE CORRECT TECHNIQUE FOR CEMENTING THE NEXGEN MIS TIBIAL COMPONENT WAS FOLLOWED. THE DEVICE IN QUESTION WAS IMPLANTED PRIOR TO THIS FIELD ACTION.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICES - NEXGEN LPS-FLEX OPTION FEMORAL F-L CATALOG #:00-5964-016-01 LOT #:60225542, NEXGEN LPS-FLEX ARTICULAR SURFACE EF 5-6, 12MM CATALOG #:00-5964-040-12 LOT #: NI, NEXGEN ALL-POLY PATELLA, 35MM X 9.0MM CATALOG #:00-5972-065-35 LOT #: NI. 510(K)/PMA NUMBER ADDED. MANUFACTURING DATE CORRECTED TO 04/01/2005. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. A COMPLAINT HISTORY SEARCH IDENTIFIED ONE (1) OTHER COMPLAINT (ASSOCIATED COMPLAINT FOR CONTRA-LATERAL SIDE) FOR LOT #60264888. SEE REPORT 1822565-2015-00653-003. THE PRIMARY SURGICAL NOTES INDICATE THAT THE PATIENT UNDERWENT RIGHT THEN LEFT MINIMAL INVASIVE TKA, DURING THE SAME SURGERY, TO TREAT ANKYLOSING SPONDYLITIS WITH BILATERAL ARTHRITIS OF THE KNEES. AFTER CRUCIATE LIGAMENT, MENISCI, AND FAT PAD RESECTION, THE PATELLA, FEMUR AND TIBIA WERE CUT AND ALL EXTRA OSTEOPHYTES REMOVED. A POSTERIOR CAPSULAR RELEASE WAS PERFORMED TO ACCENTUATE EXTENSION. THE TRIAL COMPONENTS PROVIDED EXCELLENT RANGE OF MOTION WITH GOOD STABILITY IN BOTH FLEXION AND EXTENSION, AND GOOD CENTRAL PATELLA TRACKING. THE KNEE HAD A NEAR FULL EXTENSION AND ADEQUATE FLEXION. THE TRIALS WERE REMOVED, THE LOOSE DEBRIS CLEARED, THE BONY SURFACES IRRIGATED THEN DRIED. THE FINAL FEMORAL, TIBIAL AND PATELLAR COMPONENTS WERE CEMENTED IN PLACE WITH AXIAL PRESSURE APPLIED IN EXTENSION, WITH A TRIAL POLY IN PLACE, UNTIL THE CEMENT HARDENED. ALL EXCESS CEMENT WAS REMOVED. THE KNEE WAS PUT THROUGH THE FULL RANGE OF MOTION. THE TRIAL POLY WAS REMOVED, THE DOVETAIL OF THE TIBIAL COMPONENT WAS CHECKED, AND THE FINAL ARTICULAR SURFACE WAS IMPLEMENTED AND NOTED TO SEAT WELL. THE KNEE WAS STABLE WITH GOOD RANGE OF MOTION WITH THE PATELLA TRACKING CENTRALLY. NO DROP-DOWN STEM WAS IMPLANTED. NO COMPLICATIONS WERE NOTED. THE REVISION SURGICAL NOTES STATE THAT THE PATIENT WAS REVISED DUE TO LOOSE MIS TIBIA WITH INSTABILITY AND PAIN IN THE LEFT KNEE, ABOUT 6 YEARS POST-IMPLANTATION. INTRA-OPERATIVELY A VERY AGGRESSIVE SYNOVITIS WAS NOTED AND THE INFLAMED SYNOVIUM, WHICH IS TYPICAL OF THE MIS LOOSENING SCENARIO, WAS REMOVED. THE TIBIAL COMPONENT WAS GROSSLY LOOSE; THE TIBIA HAD A FAIRLY LARGE CONTAINED DEFECT WITH BONE LOSS AND SUBSIDENCE OF THE IMPLANT. A FIELD ACTION WAS CONDUCTED ON APRIL 19, 2010 IN WHICH ZIMMER STRONGLY RECOMMENDS THE USE OF A DROP DOWN STEM EXTENSION IN CONJUNCTION WITH THE BASEPLATE AND CONFIRMING THE CORRECT TECHNIQUE FOR CEMENTING THE NEXGEN MIS TIBIAL COMPONENT WAS FOLLOWED. FDA RECALL Z-2413-2010 CONTAINS THE RELATED TIBIAL LOT NUMBER. THE DEVICE IN QUESTION WAS NOT IMPLANTED USING A DROP-DOWN STEM EXTENSION; HOWEVER THE IMPLANTATION OF THIS COMPONENT PRECEDES THE FIELD ACTION DATE. THEREFORE, PREVIOUSLY ADDRESSED PACKAGING. LABEL, OR INSTRUCTION ISSUE IS CONSIDERED AS THE ROOT CAUSE. 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 PATIENT WAS REVISED DUE TO TIBIAL LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689311 NEXGEN STEMMED MIS TIBIAL COMPONENT JWH JWH ZIMMER INC 60264888

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention