BEUDAMED
    FDA Adverse Event Death Summary report: Y

    UNKNOWN STD NCB SCREWS

    MDR report key: 22456275 · Received July 9, 2025

    Report

    Report Number
    0009613350-2025-00563
    Event Type
    Death
    Date Received
    July 9, 2025
    Date of Event
    October 2, 2024
    Report Date
    April 13, 2026
    Manufacturer
    ZIMMER GMBH
    Product Code
    HWC
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). B3: THE EVENT DATE IS THE PUBLICATION DATE OF THE ARTICLE. D1: UNKNOWN AND UNSPECIFIED NUMBER OF STANDARD NCB SCREWS D4: THE PRIMARY UNIQUE DEVICE IDENTIFICATION (UDI) NUMBER IS NOT APPLICABLE AS THE DEVICE'S PRODUCT NUMBER IS UNKNOWN. D10: UNKNOWN NCB PLATE E1: THE TRIAL WAS AN INTERNATIONAL, MULTICENTER, RANDOMIZED CONTROLLED CLINICAL TRIAL PERFORMED ACROSS 16 PARTICIPATING CENTERS IN CANADA AND THE UNITED STATES. THE METHODS CENTER, LOCATED AT THE UNIVERSITY OF BRITISH COLUMBIA IN VANCOUVER, CANADA, COORDINATED THE TRIAL. G2: CANADA JOURNAL ARTICLE CITATION: FAR CORTICAL LOCKING VERSUS STANDARD CONSTRUCTS FOR LOCKED PLATE FIXATION IN THE TREATMENT OF ACUTE, DISPLACED FRACTURES OF THE DISTAL FEMUR. LEFAIVRE, K A.; SLOBOGEAN, G; O¿HARA, N N.; O¿BRIEN, P J.; THE CANADIAN ORTHOPAEDIC TRAUMA SOCIETY (COTS) INVESTIGATORS. , ET AL. (2024) HTTP://DX.DOI.ORG/10.2106/JBJS.23.01390 THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    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

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. D4: THE PRIMARY UNIQUE DEVICE IDENTIFICATION (UDI) NUMBER IS NOT APPLICABLE AS THE DEVICE'S PRODUCT NUMBER IS UNKNOWN. ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION, AND NO FURTHER INFORMATION HAS BEEN PROVIDED. NO PRODUCT WAS RETURNED, AND NO PICTURES WERE PROVIDED; THEREFORE, A PRODUCT EVALUATION COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS COULD NOT BE PERFORMED DUE TO MISSING LOT NUMBER. A REVIEW OF THE COMPLAINT HISTORY COULD NOT BE PERFORMED DUE TO MISSING REFERENCE AND LOT NUMBERS. BASED ON THE JOURNAL ARTICLE, THE REPORTED EVENT CAN BE CONFIRMED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND THAT 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

    A JOURNAL ARTICLE WAS RETRIEVED FROM THE JOURNAL OF BONE AND JOINT SURGERY (2025) THAT REPORTED A STUDY CONDUCTED IN CANADA. THE PURPOSE OF THE STUDY WAS TO TEST THE HYPOTHESIS IN A COMPARATIVE EFFECTIVENESS CLINICAL TRIAL THAT FAR CORTICAL LOCKING (FCL) CONSTRUCTS LEAD TO IMPROVED FRACTURE-HEALING AS COMPARED WITH THAT ACHIEVED WITH TRADITIONAL LOCKING PLATES. THE TRIAL WAS AN INTERNATIONAL, MULTICENTER, RANDOMIZED CONTROLLED CLINICAL TRIAL PREFORMED ACROSS 16 PARTICIPATING CENTERS IN CANADA AND THE UNITED STATES. THE STUDY REVIEWED 167 PATIENTS (84 FCL SCREWS/83 STANDARD SCREWS) WITHIN A BROAD, HETEROGENOUS POPULATION THAT EXPERIENCED AO/OTA TYPE 33A OR 33C DISTAL FEMORAL FRACTURES. PATIENTS WERE RANDOMLY ASSIGNED TO TREATMENT WITH FCL SCREW FIXATION (NCB DISTAL FEMUR PLATE WITH NCB MOTIONLOC SCREWS; ZIMMER BIOMET) OR STANDARD SCREW FIXATION (NCB DISTAL FEMUR PLATE WITH STANDARD NCB SCREWS; ZIMMER BIOMET). THE FCL GROUP REQUIRED THE USE OF 4 BICORTICAL MOTIONLOC SCREWS FOR FIXATION IN THE SHAFT, WITH NO SPECIFIED WORKING LENGTH. THE STANDARD GROUP ALLOWED LOCKING SCREWS, NON-LOCKING SCREWS, AND HYBRID CONSTRUCTS (I.E., A MIXTURE OF LOCKING AND NON-LOCKING SCREWS) AND ANY WORKING LENGTH. THE INDICATION FOR SURGERY WAS A MECHANISM OF INJURY THAT INCLUDES THE FOLLOWING FOR THE FCL SCREW GROUP/STANDARD SCREW GROUP: DRIVER/PASSENGER IN MOTOR VEHICLE ACCIDENT (9/14), PEDESTRIAN OF MOTOR VEHICLE ACCIDENT (5/5), MOTORCYCLE ACCIDENT (8/4), FALL (58/54), DIRECT TRAUMA (1/2), AND OTHER (3/1). THE STUDY POPULATION HAD A MEAN AGE, AT THE TIME OF SURGERY, OF 63.0 ± 15.4 YEARS FOR THE FCL SCREW GROUP AND 63.9 ± 17.3 YEARS FOR THE STANDARD SCREW GROUP; MALE/FEMALE RATIO OF 27/57 WITHIN THE FCL SCREW GROUP AND 26/57 WITHIN THE STANDARD SCREW GROUP. FOLLOW-UP WAS CONDUCTED AT THREE MONTHS, SIX MONTHS, TWELVE MONTHS AFTER FIXATION. A JOURNAL ARTICLE REPORTED FOUR PATIENTS WITHIN THE STANDARD SCREW GROUP EXPIRED DUE TO AN UNKNOWN CAUSE WITHIN AN UNKNOWN TIMEFRAME. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702588 UNKNOWN STD NCB SCREWS SCREW, FIXATION, BONE HWC ZIMMER GMBH UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| D SEE H11 NARRATIVE