BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NCB®, PERIPROSTHETIC FEMUR PLATE, PROXIMAL, LEFT, 9 HOLES, 245 MM

    MDR report key: 22869577 · Received August 21, 2025

    Report

    Report Number
    0009613350-2025-00667
    Event Type
    Injury
    Date Received
    August 21, 2025
    Date of Event
    July 30, 2025
    Report Date
    December 17, 2025
    Manufacturer
    ZIMMER GMBH
    Product Code
    HRS
    UDI-DI
    00889024292741
    PMA / PMN Number
    K100111
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10. NCB®, PERIPROSTHETIC TROCHANTER PLATE, LEFT, NARROW ITEM# 0202263301 LOT# 3198677. NCB®, LOCKING CAP (X3) ITEM# 0202150300 LOT# 31997780. CABLE CERCLAGE CABLE WITH CRIMP 1.8 MM DIA. 635 MM LENGTH ITEM# 00223200418 LOT# 66673083. CABLE CERCLAGE CABLE WITH CRIMP 1.8 MM DIA. 635 MM LENGTH (X2) ITEM# 00223200418 LOT# 66662043. NCB CABLE BUTTON ITEM# 47-2232-060-01 LOT# 3139131. NCB CABLE BUTTON ITEM# 47-2232-060-01 LOT# 3171212. NCB CABLE BUTTON ITEM# 47-2232-060-01 LOT# 3200480. 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 WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT COULD NOT BE CONFIRMED DUE TO LACK OF PRODUCT/INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE DEVICE HISTORY RECORD WAS NOT REVIEWED; A REVIEW OF THE DEVICE HISTORY RECORD AND COMPLAINT HISTORY REVIEW WILL NOT BE COMPLETED FOR LIMITED INVESTIGATION COMPLAINTS AS THE PRODUCT MEETS THE APPLICABLE ACCEPTANCE CRITERIA. ROOT CAUSE HAS BEEN IDENTIFIED AS UNRELATED TO THE DEVICE. IF ANY FURTHER INFORMATION IS FOUND 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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL SURGERY WITH PROXIMAL NCB. SUBSEQUENTLY, APPROXIMATELY 8 MONTHS AND A HALF POST IMPLANTATION, PATIENT FELL AND UNDERWENT A REVISION SURGERY DUE TO DISTAL FEMUR FRACTURE. SURGEON REMOVED PROXIMAL NCB PLATE AND REPLACED IT WITH A DISTAL PLATE TO REDUCE AND REPAIR THE NEW FRACTURE. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1404290 NCB®, PERIPROSTHETIC FEMUR PLATE, PROXIMAL, LEFT, 9 HOLES, 245 MM IMPLANT, TRAUMA HRS ZIMMER GMBH 3203462 00889024292741

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Unknown Required Intervention| H SEE H11 NARRATIVE.