BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN NEXGEN RHK FEMORAL COMPONENT

    MDR report key: 13584807 · Received February 23, 2022

    Report

    Report Number
    0001822565-2022-00195
    Event Type
    Injury
    Date Received
    February 23, 2022
    Report Date
    February 23, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). FOREIGN - (B)(6). LITERATURE - VON HINTZE, J., NIEMELÄINEN, M., SINTONEN, H., NIEMINEN, J., & ESKELINEN, A. (2021). OUTCOMES OF THE ROTATING HINGE KNEE IN REVISION TOTAL KNEE ARTHROPLASTY WITH A MEDIAN FOLLOW-UP OF 6.2 YEARS. BMC MUSCULOSKELETAL DISORDERS, 22(1), 336. HTTPS://DOI.ORG/10.1186/S12891-021-04205-9 NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE DHR WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2022-00404.

    Description of Event or Problem · 0

    A JOURNAL ARTICLE WAS RETRIEVED FROM BMC MUSCULOSKELETAL DISORDERS (2021) THAT REPORTED A STUDY FROM (B)(6) THAT LOOKED AT SURVIVAL RATE AND OUTCOMES IN REVISION ROTATING HINGE KNEE (RHK) ARTHROPLASTIES. THE STUDY REPORTED ONE PATIENT EXPERIENCED ASEPTIC LOOSENING OF THE FEMUR APPROXIMATELY 7.2 YEARS POSTOP. SUBSEQUENTLY, THE PATIENT UNDERWENT REVISION OF THE POLY AND FEMORAL COMPONENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1148452 UNKNOWN NEXGEN RHK FEMORAL COMPONENT PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R