BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN NONAUGMENTABLE STEMMED TIBIAL COMPONENT

    MDR report key: 7895300 · Received September 20, 2018

    Report

    Report Number
    0002648920-2018-00694
    Event Type
    Injury
    Date Received
    September 20, 2018
    Report Date
    March 22, 2019
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    JWH
    PMA / PMN Number
    PK933785
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UDI # (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. SURGICAL NOTES WERE NOT PROVIDED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN RISK DOCUMENTATION. THE 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 · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ALL POLY PATELLA SIZE 29 MM DIA., STANDARD 8.0 MM THICKNESS, ITEM # 00597206529, LOT # 61947280; FEMORAL COMPONENT OPTION FOR CEMENTED USE ONLY, SIZE D, LEFT, ITEM # 00599601451, LOT # 61829137; ARTICULAR SURFACE SIZE CD 10 MM HEIGHT, USE WITH PLATE 3, ITEM # 00596403010, LOT # 6150816. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT; PLEASE SEE ASSOCIATED REPORTS: 0002648920-2018-00693, 3007963827-2018-00155, 0001822565-2018-05021.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT LEFT TOTAL KNEE ARTHROPLASTY AND SUBSEQUENTLY HAS EXPERIENCED CONTINUAL PAIN AND STATED THE PROSTHESIS WAS RECALLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734549 NEXGEN NONAUGMENTABLE STEMMED TIBIAL COMPONENT PROSTHESIS KNEE JWH ZIMMER MANUFACTURING B.V. N/A 61907210

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention