BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN FEMORAL COMPONENT

    MDR report key: 19027817 · Received April 2, 2024

    Report

    Report Number
    0001822565-2024-01116
    Event Type
    Injury
    Date Received
    April 2, 2024
    Date of Event
    March 12, 2024
    Report Date
    July 18, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K173057
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D10 : NEXGEN ARTICULAR SURFACE ITEM # 00596404014 LOT # 62161442. H6: MECHANICAL -(04)- FEMUR. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE WAS NOT RETURNED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). D10 - MEDICAL PRODUCT: ST PRC TIB PLT SIZE 6 CATALOG # 00-5980-047-02 LOT # 62678373 OFFSET STEM 11MMDX145MM CATALOG # 00-5988-020-11 LOT # 62475615 OFFSET STEM 14MMDX145MM CATALOG # 00-5988-020-14 LOT # 62697907 PRC AGMT BLOCK POST SZ F 5MM CATALOG # 00-5990-036-01 LOT # 62438385 PRC AGMT BLOCK POST SZ F 5MM CATALOG # 00-5990-036-01 LOT # 62495213 PRC AGMT BLOCK DIST SZ F 5MM CATALOG # 00-5990-036-10 LOT # 61975294 PRC AGMT BLOCK DIST SZ F 5MM CATALOG # 00-5990-036-10 LOT # 62485493 LCCK FEM IMPLANT SZ F-L CATALOG # 00-5994-016-91 LOT # 11012115. G2: NEW ZEALAND. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE IT WAS DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    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 PATIENT UNDERWENT A REVISION PROCEDURE NINE YEARS POST IMPLANTATION DUE TO MALROTATION AND PAIN IN KNEE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1447854 NEXGEN FEMORAL COMPONENT PROSTHESIS KNEE JWH ZIMMER BIOMET, INC. N/A 11012115

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| H SEE H10 NARRATIVE.