BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN AFFIXUS NATURAL NAIL HUMERAL NAIL SYSTEM

    MDR report key: 19619921 · Received June 26, 2024

    Report

    Report Number
    0001822565-2024-02162
    Event Type
    Injury
    Date Received
    June 26, 2024
    Report Date
    July 1, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; D2; G2; G3; G6; H1; H2; H3; H6. H6: COMPONENT CODES: MECHANICAL (G04)- IM NAIL. NO PRODUCT WAS RETURNED, OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. PART AND LOT IDENTIFICATION ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, NEITHER WERE PROVIDED. 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 WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). G2: FOREIGN: SOUTH KOREA. LITERATURE: KWON, S.; LEE, M.; LEE, H.; HWANG, J. GS HIP NAIL VERSUS AFFIXUS HIP FRACTURE NAIL FOR THE INTRAMEDULLARY NAILING OF INTERTROCHANTERIC FRACTURES. J. CLIN. MED. 2023, 12, 6720. HTTPS://DOI.ORG/10.3390/JCM12216720. H3: CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT LOCATION IS UNKNOWN. 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 THAT THE PATIENT UNDERWENT AN INITIAL HIP ARTHROPLASTY ON AND UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT THROUGH FOLLOW-UPS WITH THE SURGEON DISPLAYED RADIOGRAPHIC EVIDENCE OF DELAYED UNION. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. AT THIS TIME THERE HAS BEEN NO ADDITIONAL INFORMATION RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430377 UNKNOWN AFFIXUS NATURAL NAIL HUMERAL NAIL SYSTEM HIP PROSTHESIS/TRAUMA HSB ZIMMER BIOMET, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other