BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN PRECOAT TIBIAL COMPONENT

    MDR report key: 6404538 · Received March 14, 2017

    Report

    Report Number
    0002648920-2017-00195
    Event Type
    Injury
    Date Received
    March 14, 2017
    Date of Event
    October 27, 2015
    Report Date
    March 29, 2017
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    JWH
    PMA / PMN Number
    PK933785
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED TO ZIMMER BIOMET FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE EVENT IS IN PROGRESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCT: ZIMMER NEXGEN CR-FLEX FEMORAL COMPONENT, CATALOG #: 00-5750-014-06, LOT #: 61757888; ZIMMER NEXGEN CR ARTICULAR SURFACE, CATALOG #: 00-5952-040-14, LOT #: 61983330; ZIMMER NEXGEN ALL-POLY PATELLA, CATALOG #: 00-5972-066-32, LOT #: 61997971; HERAEUS PALACOS BONE CEMENT, CATALOG #: 00-1113-140-01, LOT #: 73774288.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT PRODUCTS: LOT NUMBER OF BONE CEMENT CORRECTED: HERAEUS PALACOS BONE CEMENT, CATALOG #: 00-1113-140-01, LOT #: 73774286. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO DEVICES WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNKNOWN. OPERATIVE NOTES FROM THE PRIMARY SURGERY STATE THAT THE PATIENT UNDERWENT RIGHT TOTAL KNEE ARTHROPLASTY DUE TO ARTHRITIS WITH A VALGUS DEFORMITY. A FEW DEGREES OF HYPEREXTENSION AND EXCELLENT STABILITY WITH A PERFECT FLEXION AND EXTENSION GAP AND ROTATIONAL STABILITY WERE NOTED WITH TRIAL COMPONENTS. THE FINAL COMPONENTS WERE IMPLANTED WITH CEMENT AND THE KNEE WAS ¿HYPEREXTENDED¿ AND HELD UNTIL THE CEMENT HAD HARDENED. NO INTRAOPERATIVE COMPLICATIONS WERE NOTED. REVIEW OF THE IMPLANTED DEVICES IDENTIFIED NO COMPATIBILITY ISSUES. OPERATIVE NOTES FROM THE REVISION SURGERY STATE THAT THE FEMORAL AND TIBIAL COMPONENTS WERE REVISED DUE TO A LOOSENING. THE PATELLAR COMPONENT WAS NOT REVISED. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. PER THE NEXGEN CR-FLEX AND LPS-FLEX GENDER SOLUTIONS PACKAGE INSERT, LOOSENING IS A KNOWN RISK OF THIS PROCEDURE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION 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.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT UNDERWENT KNEE ARTHROPLASTY REVISION SURGERY DUE TO PAIN AND LOOSENING. THE PATIENT WAS REVISED DUE TO FEMORAL AND TIBIAL COMPONENT LOOSENING APPROXIMATELY THREE YEARS AND EIGHT MONTHS AFTER THE PRIMARY SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185201 NEXGEN PRECOAT TIBIAL COMPONENT KNEE PROSTHESIS JWH ZIMMER MANUFACTURING B.V. 61896565

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R