BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SCREW

    MDR report key: 22212856 · Received June 16, 2025

    Report

    Report Number
    0001825034-2025-01735
    Event Type
    Injury
    Date Received
    June 16, 2025
    Report Date
    June 16, 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. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT.

    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 13 PATIENTS REQUIRED REOPERATION DUE TO FRACTURE FAILURE (LOSS OF REDUCTION). DUE DILIGENCE IS COMPLETE AS MULTIPLE ATTEMPTS WERE MADE; HOWEVER, NO FURTHER INFORMATION IS AVAILABLE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1683325 UNKNOWN SCREW PLATE, FIXATION, BONE HRS ZIMMER BIOMET, INC. NI UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H SEE NARRATIVE IN H11.