BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LEGACY GENDER SOLUTIONS

    MDR report key: 19614199 · Received June 26, 2024

    Report

    Report Number
    3007963827-2024-00240
    Event Type
    Injury
    Date Received
    June 26, 2024
    Date of Event
    June 11, 2024
    Report Date
    December 11, 2024
    Manufacturer
    ZIMMER ORTHOPAEDIC MFG. LTD.
    Product Code
    JWH
    UDI-DI
    00889024192218
    PMA / PMN Number
    K173057
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: B4; B5; D2; G1; G3; G6; H1; H2; H3; H6. H6: PROPOSED COMPONENT CODE - MECHANICAL (G04) - FEMUR. NO PRODUCT WAS RETURNED, OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS WERE NOT PROVIDED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. THE ROOT CAUSE OF THE REPORTED ISSUE IS ATTRIBUTED TO USE ERROR. THE FEMORAL COMPONENT USED IN THIS CASE WAS DESIGNED FOR CEMENTED FIXATION BUT WAS IMPLANTED WITHOUT CEMENT. COMPLAINT IS NOT CONFIRMED. IF ANY FURTHER INFORMATION WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: ITEM# 00-5962-030-10; LOT# 63778708. ITEM# 00-5980-037-01; LOT# 64117746. G2: FOREIGN - EVENT OCCURRED IN JAPAN. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT WAS DISCARDED. 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.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE REVISION APPROXIMATELY FIVE (5) YEARS AND EIGHT (8) MONTHS POST-IMPLANTATION DUE TO LOOSENING. SUBSEQUENTLY, IT WAS DISCOVERED DURING THE REVISION THAT THE FEMORAL COMPONENT WAS IMPLANTED WITHOUT CEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595945 NEXGEN LEGACY GENDER SOLUTIONS PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED JWH ZIMMER ORTHOPAEDIC MFG. LTD. NI 63891375 00889024192218

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Required Intervention| H