BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LAG SCREW

    MDR report key: 19657366 · Received July 2, 2024

    Report

    Report Number
    0001822565-2024-02218
    Event Type
    Injury
    Date Received
    July 2, 2024
    Report Date
    July 1, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HSB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT HIP ARTHROPLASTY ON AND UNKNOWN DATE DUE TO INTERTROCHANTERIC FRACTURE. IMMEDIATELY POSTOP X-RAYS SHOWED A MISMATCH IN ROTATION. SIX (6) MONTHS POSTOP X-RAY SHOWED REDUCTION LOSS AND THE PROGRESSION OF VARUS DEFORMITY, WITH THE LAG SCREW EXPERIENCING CUT-OUT. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION SURGERY ON AND UNKNOWN DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756619 UNKNOWN LAG SCREW IMPLANT/TRAUMA HSB ZIMMER BIOMET, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Required Intervention| H