BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HFN A/R SCREW 80MM

    MDR report key: 13307840 · Received January 20, 2022

    Report

    Report Number
    0001825034-2022-00130
    Event Type
    Injury
    Date Received
    January 20, 2022
    Date of Event
    December 10, 2021
    Report Date
    March 8, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HSB
    PMA / PMN Number
    K100238
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: HFN LAG SCREW 10.5MM X 100MM CAT: 814510100 LOT: WN1111300A. HFN IN CAP FLUSH IMPINGING CAT: 814503101 LOT: WP1111D. HFN 130 DEG 12MM X 165MM CAT: 816812165 LOT: 982150. CORTICAL BONE SCR 5.0MM X 38MM CAT: 814550038 LOT: M26301A. REPORT SOURCE: FOREIGN: (B)(6). 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 REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED DAMAGE TO THE 2 DISTAL THREADS OF THE AR SCREW AND WEAR LINES ON THE SHAFT, HOWEVER IT CANNOT BE DETERMINED WHEN THE DAMAGE OCCURRED (WHETHER DURING IMPLANTING, IN VIVO, OR EXPLANTING). DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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 WAS REVISED DUE TO IMPLANT MIGRATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80383 HFN A/R SCREW 80MM SCREW, FIXATION HSB ZIMMER BIOMET, INC. WG1111280A

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| R SEE H10