BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLUSH IMPING 1ST SCREW

    MDR report key: 11320907 · Received February 12, 2021

    Report

    Report Number
    0001825034-2021-00446
    Event Type
    Injury
    Date Received
    February 12, 2021
    Report Date
    July 9, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HSB
    PMA / PMN Number
    K033878
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: INITIAL VIEW DEMONSTRATES THE PROXIMAL ASPECT OF A HUMERAL NAIL WITH INTERLOCKING SCREWS AND NO ABNORMALITY. SUBSEQUENT VIEW DEMONSTRATES INTERVAL LOOSENING OF THE HUMERAL NAIL END CAP. FIXATION SCREWS REMAIN INTACT AND UNCHANGED IN POSITION. ROOT CAUSE WAS UNABLE TO 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

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 1817-09-221 UNIVERSAL HUM NAIL 9X220MM M16577, 1818-48-046 4.8MM CANC SCREW STERILE 46MM M16366A, 1818-48-050 4.8MM CANC SCREW STERILE 50MM M06468F, 8050-45-034 4.5 SOLID CORT FT X 34MM M09628B, 8050-45-036 4.5 SOLID CORT FT X 36MM M12770A, 8050-45-038 4.5 SOLID CORT FT X 38MM M04323F, 8050-45-040 4.5 SOLID CORT FT X 40MM M03283F. REPORT SOURCE: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANT LOOSENED AFTER IMPLANTATION. A REVISION PROCEDURE HAS NOT OCCURRED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222298 FLUSH IMPING 1ST SCREW SCREW, FIXATION HSB ZIMMER BIOMET, INC. M17352A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other