BEUDAMED
    FDA Adverse Event Injury Summary report: N

    Z NAIL CMF 10.5 X 90 LAG SCR

    MDR report key: 23109818 · Received September 22, 2025

    Report

    Report Number
    0009613350-2025-00720
    Event Type
    Injury
    Date Received
    September 22, 2025
    Date of Event
    August 21, 2025
    Report Date
    February 27, 2026
    Manufacturer
    ZIMMER GMBH
    Product Code
    HSB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4): THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, D2A, D10, G3, G6, H2, H3, H6, H11 D10: ITEM # 47250106550, Z NAIL CMF 5.0X65 ANT SUP SCR, LOT # 3203335. ITEM # 47249818011, Z NAIL CMF 11.5MMX17.5CM 125R, LOT # 3084433. THE PRODUCTS INVOLVED IN THE REPORTED EVENT WERE NOT RETURNED FOR INVESTIGATION; HOWEVER, PICTURES WERE PROVIDED AND REVIEWED. BASED ON REVIEW OF THE PROVIDED PHOTOGRAPHIC DOCUMENTATION OF THE NAIL SYSTEM, EVIDENCE OF FRETTING AND ABRASIVE WEAR WAS IDENTIFIED AT THE INTERFACE SURFACES BETWEEN THE LAG SCREW AND THE NAIL. WEAR MARKS AND SURFACE BURNISHING ARE VISIBLE ON THE MID-TO-DISTAL PORTION OF THE LAG SCREW. MATCHING WEAR IS ALSO VISIBLE ON THE INNER BORE OF THE NAIL WHERE THE LAG SCREW SITS. THE PRESENCE OF WEAR ON BOTH CONTACT SURFACES INDICATES THAT THE TWO COMPONENTS MOVED RELATIVE TO ONE ANOTHER WHILE IMPLANTED. THE REMAINING COMPONENTS OF THE CONSTRUCT ¿ COMPRISING THE ANTI-ROTATION SCREW, END CAP/SET SCREW, AND BOTH CORTICAL LOCKING SCREWS ¿ APPEAR VISUALLY INTACT AND UNREMARKABLE IN THE PROVIDED IMAGES, WITH NO EVIDENCE OF MECHANICAL DAMAGE, DEFORMATION, OR SURFACE DEGRADATION IDENTIFIABLE UPON PHOTOGRAPHIC REVIEW. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS FOR THE LAG AND ANTI-ROTATION SCREWS. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS THAT COULD BE RELATED TO THE REPORTED EVENT FOR THE NAIL. THE REPORTED PRODUCTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. REVIEW OF THE COMPLAINT HISTORY IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED LAG SCREW ITEM AND NO ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED PART AND LOT COMBINATION. COMPLAINTS ARE MONITORED PER COMPLAINT TRENDING PROCESS IN ORDER TO IDENTIFY POTENTIAL ADVERSE TRENDS. REVIEW OF THE COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED COMPLAINTS FOR THE NAIL AND ANTI-ROTATION ITEMS AND THE REPORTED PART AND LOT COMBINATIONS. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A RADIOLOGIST. THE REVIEW IDENTIFIED AN AP AND LATERAL FLUOROSCOPIC INTRAOPERATIVE IMAGES OF THE RIGHT HIP SHOW INTRAMEDULLARY NAIL AND FEMORAL NECK LAG SCREW FIXATION OF RIGHT INTERTROCHANTERIC FRACTURE. ADDITIONAL ANTIROTATIONAL FEMORAL NECK SCREW IN PLACE. MINIMAL RESIDUAL FRACTURE DISPLACEMENT WITH MILD POSTERIOR ANGULATION NOTED AND NO IMMEDIATE HARDWARE COMPLICATION IDENTIFIED. FOLLOW-UP AP AND FROGLEG LATERAL VIEWS OF THE RIGHT HIP ON THE FIRST POSTOPERATIVE AVAILABLE DATE SHOWS COMPRESSION AT THE FRACTURE SITE WITH BACKOUT OF THE LARGE LAG SCREW OUTER CANNULA AND ANTIROTATIONAL SCREW. PERSISTENT VISUALIZATION OF THE FRACTURE LINE IS SUSPICIOUS FOR NON-UNION. THE SECOND POSTOPERATIVE VISIT SHOWS UNCHANGED ALIGNMENT AT THE FRACTURE SITE BUT INTERVAL ADVANCE OF THE LARGE FEMORAL NECK SCREW, NOW PENETRATING THE MEDIAL CORTEX OF THE FEMORAL HEAD AS WELL AS ADVANCE OF THE ANTIROTATIONAL SCREW, CONSISTENT WITH HARDWARE LOOSENING/LOSS OF FIXATION. PERSISTENT VISUALIZATION OF THE FRACTURE LINE IS AGAIN NOTED, SUSPICIOUS FOR NON-UNION. RADIOGRAPHIC OSTEOPENIA IS NOTED. THE WEAR OBSERVED ON BOTH THE LAG SCREW AND NAIL BORE IS CONSISTENT WITH RELATIVE MICRO-MOTION BETWEEN THE TWO COMPONENTS DURING THE PERIOD OF IMPLANTATION, WHICH ALIGNS WITH THE DEVICE MIGRATION OBSERVED ON THE RADIOGRAPHIC IMAGING. HOWEVER, 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.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: ITEM # 47249818011, Z NAIL CMF 11.5MMX17.5CM 125R, LOT # 3084433. G2: REPORT SOURCE JAPAN. 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 MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INITIAL OPERATION WAS PERFORMED WITH CM FORTIS NAIL SYSTEM. THE PATIENT'S POSTOPERATIVE COURSE WAS GOOD, BUT AT A ROUTINE CHECKUP WAS DISCOVERED THAT THE LAG SCREW HAD PENETRATED THE FEMORAL HEAD. THEREFORE, A REVISION SURGERY WAS PERFORMED APPROXIMATELY 10 MONTHS POST IMPLANTATION, IN WHICH ALL THE ORIGINALLY IMPLANTED IMPLANTS WERE REMOVED, AND IT WAS REPLACED WITH AN IMPLANT FROM ANOTHER MANUFACTURER. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2069929 Z NAIL CMF 10.5 X 90 LAG SCR TRAUMA, SCREW HSB ZIMMER GMBH 3188640

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| H