BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LAG SCREW

    MDR report key: 15437123 · Received September 16, 2022

    Report

    Report Number
    0009613350-2022-00482
    Event Type
    Injury
    Date Received
    September 16, 2022
    Date of Event
    October 14, 2021
    Report Date
    September 16, 2022
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURER GMBH
    Product Code
    HWC
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORT SOURCE - FOREIGN: FRANCE. CONCOMITANT MEDICAL PRODUCTS: ITEM NAME: CMN FEMORAL NAIL, CCD 130°, RIGHT, 11.5 MM, 38 CM; ITEM#: 47249338211; LOT#: 2820901. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. BASED ON THE 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0009613350 -2022 -00353.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A FEMORAL NAIL AND SCREW. AROUND 2.5 YEARS LATER, THE BONE HAD CONSOLIDATED AND THE PATIENT WAS FEELING DISCOMFORT SO A REVISION SURGERY TOOK PLACE. DURING THIS REVISION SURGERY, WHILE REMOVING THE LAG SCREW, FRACTURE OF THE WINGS MADE THE REMOVAL OF BOTH IMPLANTS IMPOSSIBLE. THE REVISION SURGERY HAD TO BE RESCHEDULED. THE PATIENT UNDERWENT 2ND REVISION SURGERY, IN THIS SURGERY SCREW AND NAIL WERE REMOVED WITHOUT DIFFICULTY. NO FURTHER PATIENT OUTCOME PROVIDED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125354 UNKNOWN LAG SCREW TRAUMA PROSTHESIS HWC ZIMMER SWITZERLAND MANUFACTURER GMBH N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Hospitalization| R