BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    UNKNOWN LAG SCREW

    MDR report key: 21936531 · Received April 30, 2025

    Report

    Report Number
    0009613350-2025-00352
    Event Type
    Injury
    Date Received
    April 30, 2025
    Report Date
    March 26, 2026
    Manufacturer
    ZIMMER GMBH
    Product Code
    HSB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). A2: AGE OF PATIENT: RANGE OF 50-96 YEARS B3, D6B: BETWEEN (B)(6) 2021 G2: REPORT SOURCE TURKEY. REPORT SOURCE: "LITERATURE: VAHABI A, DASTAN AE, KILICLI B, ALJASIM O, GUNAY H, OZKAYIN N, AKTUGLU K. 2024. COMPARATIVE ANALYSIS OF RADIO-LOGICAL OUTCOMES AMONG CEPHALOMEDULLARY NAILS: HELICAL, SCREW AND WINGED SCREW. PAGES 1-16. HTTP://DOI.ORG/10.7717/PEERJ.18020". NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; 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 AVAILABLE INFORMATION, THE REPORTED EVENT CAN BE CONFIRMED. CORRESPONDENCE WITH THE AUTHOR OF THE STUDY, POINT OUT AS POSSIBLE CONTRIBUTING FACTOR FOR THE REPORTED EVENT INAPPROPRIATE TIP-APEX DISTANCES, LOW BONE QUALITY OR NON-ANATOMICAL REDUCTION.; ADDITIONALLY, MORE ELDERLY PATIENTS WITH LOWER BONE MINERAL DENSITY TEND TO FAIL CONSIDERING THEY DO NOT TOLERATE SUBOPTIMAL REDUCTION OR TIP APEX DISTANCES. HOWEVER, WITH THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE CANNOT BE ESTABLISHED. 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.

    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 -(B)(4) 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.

    Description of Event or Problem · 0

    ON 13FEB2025, A JOURNAL ARTICLE WAS RETRIEVED FROM PEERJ 2024 THAT REPORTED A STUDY FROM TURKEY. THE PURPOSE OF THE STUDY WAS TO COMPARE THE RADIOLOGICAL OUTCOMES AND MECHANICAL COMPLICATIONS OF FEMORAL TROCHANTERIC FRACTURES TREATED WITH THREE DIFFERENT CMNS; ZIMMER BIOMET AND 2 COMPETITOR PRODUCTS. PLEASE NOTE WITHIN THE ARTICLE THE NAMING OF ZIMMER BIOMET PRODUCT IS NOT CONSISTENT AND IS REPORTED AS THE FOLLOWING: GROUP II, GROUP 2, GROUP B, SCREW, OR SCREW-TYPE BLADE. THE STUDY RETROSPECTIVELY REVIEWED 158 CASES OF CLOSED INTERTROCHANTERIC FRACTURES TREATED BETWEEN JANUARY 2016-DECEMBER 2021, 53 OF WHICH RECEIVED THE ZNN CEPHALOMEDULLARY NAILS SYSTEM. THE ZNN STUDY POPULATION HAD A MEAN AGE OF 74.1 YEARS AT TIME OF SURGERY AND RANGE OF 50 96; WITH 20 MALES/33 FEMALES. FOLLOW-UP WAS CONDUCTED WITH A MEAN LENGTH OF FOLLOW-UP FOR 12.7 MONTHS. IT WAS REPORTED THAT 7 PATIENTS THAT DISPLAYED EVIDENCE OF THE MECHANICAL COMPLICATION PRODUCT ¿CUT-OUT¿. DEPENDING ON REMAINING BONE STOCK IN FEMORAL HEAD A REVISION WAS PERFORMED WITH CMN OR PROCEEDED WITH ARTHROPLASTY. DUE DILIGENCE HAS BEEN COMPLETED FOR THIS COMPLAINT; TO DATE ALL AVAILABLE ADDITIONAL INFORMATION HAS BEEN RECEIVED.

    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
    309369 UNKNOWN LAG SCREW CEPHALOMEDULLARY NAILS SYSTEM HSB ZIMMER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R SEE H11 NARRATIVE.