BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN CR-FLEX FEMORAL COMPONENT PRECOAT

    MDR report key: 6404535 · Received March 14, 2017

    Report

    Report Number
    3007963827-2017-00026
    Event Type
    Injury
    Date Received
    March 14, 2017
    Date of Event
    October 27, 2015
    Report Date
    March 29, 2017
    Manufacturer
    ZIMMER ORTHOPAEDIC MFG. LTD.
    Product Code
    JWH
    PMA / PMN Number
    PK060370
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MEDICAL PRODUCT: ZIMMER NEXGEN TIBIAL COMPONENT CATALOG #: 00-5980-047-01 LOT #: 61896565, 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. UNABLE TO CONFIRM COMPLAINT, DEVICE NOT RETURNED, KNOWN INHERENT RISK OF THE PROCEDURE. 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
    185198 NEXGEN CR-FLEX FEMORAL COMPONENT PRECOAT KNEE PROSTHESIS JWH ZIMMER ORTHOPAEDIC MFG. LTD. 61757888

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R