BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NCB PP PR FEM PLT L15H L324MM

    MDR report key: 21762826 · Received April 3, 2025

    Report

    Report Number
    0009613350-2025-00216
    Event Type
    Injury
    Date Received
    April 3, 2025
    Date of Event
    March 11, 2025
    Report Date
    June 11, 2025
    Manufacturer
    ZIMMER GMBH
    Product Code
    HRS
    UDI-DI
    00889024292765
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4): THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; A PRODUCT EVALUATION COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS THAT COULD BE RELATED TO THE REPORTED EVENT. REVIEW OF THE COMPLAINT HISTORY IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEM AND THE PART AND LOT COMBINATION. COMPLAINTS ARE MONITORED PER COMPLAINT TRENDING PROCESS IN ORDER TO IDENTIFY POTENTIAL ADVERSE TRENDS. A COMPLAINT TREND WAS DETECTED DURING THE MCTR AND ISSUE EVALUATION (B)(4) HAS BEEN INITIATED FOR NCB PP FEMUR PLATE FRACTURES. BASED ON THE AVAILABLE INFORMATION, THE REPORTED EVENT CANNOT BE CONFIRMED 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): THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: A1, A2, B4, D1, D4, D6A, D10, G3, G6, H2, H4, H11. D10: ITEM # 00223200418, CABLE CERCLAGE CABLE WITH CRIMP 1.8 MM DIA. 635 MM LENGTH, LOT # 66254304 ITEM # 0202151020, UNICORTICAL SCREW 5.0 MM DIAMETER 20 MM LENGTH WARNING: THIS DEVICE IS NOT APPROVED FOR SCREW ATTACHMENT OR FIXATION, LOT # 64297298. ITEM # 0202150032, NCB®, CORTICAL SCREW, 5.0 MM, 32 MM, LOT # 3072785 ITEM # 0202151016, UNICORTICAL SCREW 5.0 MM DIAMETER 16 MM LENGTH WARNING: THIS DEVICE IS NOT APPROVED FOR SCREW ATTACHMENT OR FIXATION, LOT # 63970835 ITEM # 0202151018, UNICORTICAL SCREW 5.0 MM DIAMETER 18 MM LENGTH WARNING: THIS DEVICE IS NOT APPROVED FOR SCREW ATTACHMENT OR FIXATION, LOT # 63970833 ITEM # 0202150300, NCB®, LOCKING CAP, LOT # 3166991. 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). G2: REPORT SOURCE AUSTRALIA. 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 PATIENT UNDERWENT REVISION DUE TO AN NCB PLATE FRACTURE APPROXIMATELY 10 MONTHS POST-IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT UNDERWENT REVISION DUE TO AN NCB PLATE FRACTURE AN UNKNOWN AMOUNT OF TIME AFTER IMPLANTATION. 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
    654685 NCB PP PR FEM PLT L15H L324MM TRAUMA, PLATE. HRS ZIMMER GMBH 3156506 00889024292765

    Patients

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