BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN FEMORAL COMPONENT

    MDR report key: 12165883 · Received July 14, 2021

    Report

    Report Number
    0001822565-2021-01871
    Event Type
    Injury
    Date Received
    July 14, 2021
    Report Date
    July 8, 2021
    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
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOREIGN - REPUBLIC OF KOREA. LITERATURE: HAN, H. S., & LEE, M. C. (2017). CEMENTING TECHNIQUE AFFECTS THE RATE OF FEMORAL COMPONENT LOOSENING AFTER HIGH FLEXION TOTAL KNEE ARTHROPLASTY. THE KNEE, 24(6), 1435¿1441. HTTPS://DOI.ORG/10.1016/J.KNEE.2017.08.002. 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. MEDICAL RECORDS WERE NOT PROVIDED. 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.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS RETRIEVED FROM THE KNEE (2017) THAT REPORTED A STUDY FROM THE REPUBLIC OF KOREA THAT LOOKED AT FEMORAL COMPONENT LOOSENING AFTER HIGH FLEXION TOTAL KNEE ARTHROPLASTY. THE PURPOSE OF THE STUDY WAS TO DETERMINE THE EFFECTS OF DIFFERENT CEMENTING TECHNIQUES ON THE RATE OF EARLY FEMORAL LOOSENING OF HIGH-FLEXION TOTAL KNEE ARTHROPLASTIES. THE STUDY REVIEWED SEVEN HUNDRED AND THIRTY-FOUR (734) KNEES RECEIVING A NEXGEN LEGACY POSTERIOR STABILIZED-FLEX FIXED BEARING PROSTHESIS FROM JULY 2001 TO JULY 2010. THE STUDY POPULATION HAD A MEAN AGE OF 69.1 ±6.9 YEARS AT TIME OF SURGERY. FOLLOW-UP WAS CONDUCTED AT CLINICALLY AND RADIOGRAPHICALLY AT SIX WEEKS, THREE MONTHS, SIX MONTHS, ONE YEAR AND ANNUALLY THEREAFTER WITH A MEAN LENGTH OF FOLLOW-UP FOR 8.3 YEARS (GROUP N) AND 5.8 YEARS (GROUP P). THE STUDY REPORTED NINE FEMORAL REVISIONS DUE TO ASEPTIC LOOSENING. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1062781 UNKNOWN FEMORAL COMPONENT PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R