BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN FEMORAL COMPONENT SIZE D LEFT

    MDR report key: 7895291 · Received September 20, 2018

    Report

    Report Number
    3007963827-2018-00155
    Event Type
    Injury
    Date Received
    September 20, 2018
    Report Date
    March 22, 2019
    Manufacturer
    ZIMMER ORTHOPAEDIC MFG. LTD.
    Product Code
    NJL
    PMA / PMN Number
    PP060037
    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; NONAUGMENTABLE STEMMED TIBIAL COMPONENT OPTION, SIZE 3, ITEM # 00598603701, LOT # 61907210; 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, 0002648920-2018-00694, 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
    734300 NEXGEN FEMORAL COMPONENT SIZE D LEFT PROSTHESIS KNEE NJL ZIMMER ORTHOPAEDIC MFG. LTD. N/A 61829137

    Patients

    Seq Age Sex Outcome Treatment
    1 Other