BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN ARTICULAR SURFACE

    MDR report key: 9744094 · Received February 24, 2020

    Report

    Report Number
    0001822565-2020-00677
    Event Type
    Injury
    Date Received
    February 24, 2020
    Report Date
    March 4, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K173057
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: NEXGEN FEMORAL COMPONENT CATALOG # 00595001705 LOT # 62030648, NEXGEN STEMMED TIBIAL COMPONENT CATALOG # 00598605701 LOT # 62082093, NEXGEN ALL POLY PATELLA CATALOG # 00597206538 LOT # 62038969, PATELLA REAMER BLADE WITH PILOT HOLE 41 MM DIAMETER SINGLE USE ONLY CATALOG # 00597909541 LOT # 62011787. MULTIPLE MDR: 3007963827-2020-00058, 0002648920-2020-00103, 0002648920-2020-00102

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. PROCEDURAL RELATED COMPLICATIONS ARE INFLUENCED BY THE TYPE OF SURGERY, PATIENTS PRE-EXISTING COMORBID STATE, AND PERIOPERATIVE MANAGEMENT. DEEP VEIN THROMBOSIS, OR DVT, OCCURS WHEN A BLOOD CLOT FORMS IN ONE OF THE DEEP VEINS OF THE BODY. THIS CAN HAPPEN IF A VEIN BECOMES DAMAGED OR IF THE BLOOD FLOW WITHIN A VEIN SLOWS DOWN OR STOPS. TOTAL JOINT PATIENTS ARE TYPICALLY PLACED ON MEDICATION POST-OPERATIVE FOR A PERIOD OF TIME TO PREVENT THE DEVELOPMENT OF DVT/BLOOD CLOT. EVEN WITH THE ADMINSTRATION OF PREVENTIVE MEDICATION, DVT/BLOOD CLOTS CAN STILL DEVELOP. AS THE COMPLAINT INDICATED A POST-OPERATIVE COMPLICATION DEVELOPED AND IT CAN BE IMPLIED MEDICAL INTERVENTION WAS REQUIRED TO TREAT THE COMPLICATION. 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 · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). IMPLANT DATE: (B)(6) 2012. CONCOMITANT MEDICAL PRODUCTS: UNKNOWN NEXGEN FEMORAL COMPONENT CATALOG # UNKNOWN LOT # UNKNOWN. UNKNOWN NEXGEN TIBIAL COMPONENT CATALOG # UNKNOWN LOT # UNKNOWN. THE COMPLAINANT HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILLED FOR THIS EVENT: 0001822565-2020-00675, 0001822565-2020-00676. DEVICE EVALUATED BY MANUFACTURER? REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE ARTHROPLASTY. SUBSEQUENTLY,THE PATIENT WAS EXPERIENCING DEEP VEIN THROMBOSIS POSTOPERATIVE, WHICH WAS RESOLVED. MEDICAL RECORDS STATES THAT NO FURTHER ISSUES OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209621 NEXGEN ARTICULAR SURFACE PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 62061802

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention