BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN STEM

    MDR report key: 13538459 · Received February 15, 2022

    Report

    Report Number
    0001822565-2022-00407
    Event Type
    Injury
    Date Received
    February 15, 2022
    Report Date
    February 15, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    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: 0001822565-2022-00231.

    Description of Event or Problem · 0

    A JOURNAL ARTICLE WAS RETRIEVED FROM BMC MUSCULOSKELETAL DISORDERS (2021) THAT REPORTED A STUDY FROM FINLAND THAT LOOKED AT SURVIVAL RATE AND OUTCOMES IN REVISION ROTATING HINGE KNEE (RHK) ARTHROPLASTIES. THE STUDY REPORTED 2 PATIENTS EXPERIENCED A PERIPROSTHETIC FEMORAL FRACTURE AND WERE TREATED OPERATIVELY; OF WHICH, ONE WAS TREATED WITH OSTEOSYNTHESIS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1735225 UNKNOWN STEM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R