BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HFN LAG SCREW 10.5MM X 110MM

    MDR report key: 7359370 · Received March 21, 2018

    Report

    Report Number
    0001825034-2018-02104
    Event Type
    Injury
    Date Received
    March 21, 2018
    Date of Event
    February 2, 2018
    Report Date
    June 7, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HSB
    PMA / PMN Number
    PK100238
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. THE PRODUCT WAS EVALUATED THROUGH MANUFACTURING REVIEW AND THE COMPLAINT WAS CONFIRMED THROUGH RADIOGRAPHIC REVIEW. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE IDENTIFIED. MEDICAL RECORDS WERE NOT PROVIDED FOR THIS EVENT, HOWEVER, THE COMPLAINANT STATED, "ACCORDING TO THE SURGEON, THE PATIENT IGNORED FOLLOW-UP AND MAY HAVE BEEN FULL WEIGHT BEARING." A RADIOGRAPHIC REVIEW INDICATED THAT "MILD RADIOLUCENCY SURROUNDING THE LAG SCREW SUGGESTS POSSIBLE LOOSENING. NO DEFINITE EVIDENCE FOR LAG SCREW MIGRATION." WHILE IT IS NOTED THAT THE SURGEON BELIEVES NONCOMPLIANCE MAY HAVE PLAYED A ROLE IN THE REPORTED EVENT, THIS CANNOT BE CONFIRMED AS THE ROOT CAUSE. BASED ON AVAILABLE INFORMATION, 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. THE REPORTED DEVICE IS USED FOR TREATMENT.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 814313180, HFN 125 DEG 13MM X 180MM, 123690, 814550042, CORTICAL BONE SCR 5.0MM X 42MM, NM08921TWA, 814501100, HFN A/R SCREW 100MM, TK1112300A. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. DISCARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S LAG SCREW WAS REVISED DUE TO MIGRATION INTO THE PATIENT'S FEMORAL HEAD WHICH CAUSED PAIN. IT WAS REPORTED PATIENT NON-COMPLIANCE MAY HAVE CONTRIBUTED TO THE EVENT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201872 HFN LAG SCREW 10.5MM X 110MM ROD, FIXATION HSB ZIMMER BIOMET, INC. N/A TP1111310A

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R