BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK SCREW

    MDR report key: 22283696 · Received June 18, 2025

    Report

    Report Number
    0001825034-2025-01768
    Event Type
    Injury
    Date Received
    June 18, 2025
    Report Date
    June 17, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HRS
    PMA / PMN Number
    NI
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: ITEM# UNK DVR PLATE; LOT# UNKNOWN. G2: FOREIGN - EVENT OCCURRED IN NORWAY. G2: LITERATURE - OLSEN, O.-G., OMRANI, S., AMUNDSEN, A., HAUGSTVEDT, J. R., SAMUELSSON, K., & ÖSTMAN, B. (N.D.). THE RATE OF MAJOR COMPLICATIONS FOLLOWING DISTAL RADIAL FRACTURES TREATED WITH ONE SPECIFIC VOLAR LOCKING PLATE: A RETROSPECTIVE STUDY OF 1,597 CONSECUTIVE CASES IN 1,564 PATIENTS. JOURNAL OF HAND SURGERY. DOI: 10.1016/J.JHSA.2025.01.022. ATTEMPTS HAVE BEEN MADE TO GATHER PRODUCT ID INFORMATION AND NO FURTHER INFO IS AVAILABLE. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS WERE NOT PROVIDED. PART AND LOT IDENTIFICATION ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, NEITHER WERE PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE REPORTED EVENT IS UNCONFIRMED. IF ANY FURTHER INFORMATION WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY THREE (3) WEEKS AGO, A JOURNAL ARTICLE WAS RETRIEVED FROM AMERICAN SOCIETY FOR SURGERY OF THE HAND (2025) THAT REPORTED A RETROSPECTIVE COHORT STUDY FROM NORWAY. THE PURPOSE OF THE STUDY WAS TO FIND THE INCIDENCE OF COMPLICATIONS LEADING TO REOPERATION IN A SAMPLE OF DISTAL RADIUS FRACTURES TREATED WITH ONE SPECIFIC VOLAR LOCKING PLATE (VLP). THE STUDY REVIEWED 1,597 DISTAL RADIUS FRACTURES IN 1,564 PATIENTS OPERATED WITH A VLP. FIXATION WAS ACCOMPLISHED USING A MODIFIED HENRY¿S VOLAR APPROACH WITH A ¿DISTAL FIXATION FIRST¿ TECHNIQUE UNDER FLUOROSCOPY GUIDANCE. THE ZIMMER BIOMET DISTAL VOLAR RADIUS PLATE (DVR) WAS IMPLANTED IN ALL CASES. POSTOP, PATIENTS WERE CASTED 2-6 WEEKS AS NEEDED BASED ON INJURY. THE STUDY REPORTED THAT 1 PATIENT REQUIRED REOPERATION DUE TO DE QUERVAIN¿S SYNDROME. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1723852 UNK SCREW PLATE, FIXATION, BONE HRS ZIMMER BIOMET, INC. NI UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R