BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    UNKNOWN TRAUME SCREW

    MDR report key: 22346024 · Received June 27, 2025

    Report

    Report Number
    0001825034-2025-01897
    Event Type
    Injury
    Date Received
    June 27, 2025
    Date of Event
    March 10, 2025
    Report Date
    March 30, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HWC
    PMA / PMN 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). - G2: FOREIGN - THE EVENT OCCURRED IN NORWAY. - G2: JOURNAL ARTICLE - OLSEN, O., OMRANI, S., AMUNDSEN, A., HAUGSTVEDT, J. R., SAMUELSSON, K., & ÖSTMAN, B. (2025). 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. THE JOURNAL OF HAND SURGERY. HTTPS://DOI.ORG/10.1016/J.JHSA.2025.01.022. THE CUSTOMER HAS NOT INDICATED WHETHER THE PRODUCT WILL BE ZIMMER BIOMET FOR INVESTIGATION, AND THE PRODUCT LOCATION IS UNKNOWN. ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION, AND NO FURTHER INFORMATION HAS BEEN PROVIDED. THE REPORTED EVENT IS UNCONFIRMED. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. PART AND LOT IDENTIFICATION ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, NEITHER WERE PROVIDED. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: B4, B5, D2, G1, G3, G6, H1, H2, H11. H1: THIS MDR IS BEING SUBMITTED AS A PART OF A RETROSPECTIVE LITERATURE MDR REPORTING REVIEW AND REMEDIATION EFFORT BASED ON MDR REPORTING PROCESS AND FDA ADVERSE EVENT REPORTING REQUIREMENT. CAPA -07984 WAS OPENED ON FEB 27, 2026, TO ADDRESS CORRECTIONS. DEVICE PERFORMANCE AND/OR RISK PROFILE ARE NOT IMPACTED. 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, G3, H2, H6 THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE MADE. REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED AS PART AND LOT IDENTIFICATION WERE NOT PROVIDED. NO MEDICAL RECORDS WERE PROVIDED. A DEFINITIVE ROOT CAUSE COULD NOT 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

    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 FROM JANUARY 2011 TO DECEMBER 2017. 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 POPULATION HAD A MEAN AGE OF 62 YEARS AT TIME OF SURGERY (RANGE 18-94 YEARS) WITH 330 MALES AND 1,267 FEMALES. POSTOPERATIVE ELECTRONIC MEDICAL RECORDS AND RADIOLOGY REPORTS WERE REVIEWED FOR A MINIMUM OF 5 YEARS AFTER SURGERY. THE STUDY REPORTED THAT 3 PATIENTS REQUIRED REOPERATION DUE TO PERI-IMPLANT FRACTURE.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    974011 UNKNOWN TRAUME SCREW SCREW, FIXATION, BONE HWC ZIMMER BIOMET, INC. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H