BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NCB CRVD FEM SHAF PLT 10H210MM

    MDR report key: 22520968 · Received July 16, 2025

    Report

    Report Number
    0009613350-2025-00604
    Event Type
    Injury
    Date Received
    July 16, 2025
    Date of Event
    June 20, 2025
    Report Date
    October 22, 2025
    Manufacturer
    ZIMMER GMBH
    Product Code
    HRS
    UDI-DI
    00889024484238
    PMA / PMN Number
    K100111
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, G3, G6, H2, H3, H6, H11 THE REPORTED EVENT COULD NOT BE CONFIRMED DUE TO LACK OF PRODUCT/INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; A PRODUCT EVALUATION COULD NOT BE PERFORMED. UNDATED RADIOGRAPHS WERE PROVIDED, THEREFORE IT IS IMPOSSIBLE TO CONNECT THE REPORTED EVENT WITH THE ONSET OF SYMPTOMS. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). D10. CABLE READY CERCLAGE CABLE WITH CRIMP ITEM# 2232-04-18 LOT# 66094364. CABLE READY CERCLAGE CABLE WITH CRIMP ITEM# 2232-04-18 LOT# 66004570. CABLE READY CERCLAGE CABLE WITH CRIMP ITEM# 2232-04-18 LOT# 62703650. CABLE READY CERCLAGE CABLE WITH CRIMP ITEM# 2232-04-18 LOT# 66094364. CABLE BUTTON FOR NCB POLYAXIAL LOCKING PLATE ITEM# 47-2232-060-01 LOT# 3149852. CABLE BUTTON FOR NCB POLYAXIAL LOCKING PLATE ITEM# 47-2232-060-01 LOT# 3160701. CABLE BUTTON FOR NCB POLYAXIAL LOCKING PLATE ITEM# 47-2232-060-01 LOT# 3164734. CABLE BUTTON FOR NCB POLYAXIAL LOCKING PLATE ITEM# 47-2232-060-01 LOT# 3155728. 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.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NCB CURVED PLATE WAS USED FOR A PERI PROSTHETIC FRACTURE, FRACTURE HEALED BUT PATIENT HAS HAD PAIN ON THAT LEG. PLATE MAY HAVE MOVED DUE TO BIOLOGICAL CHANGES IN THE PATIENT'S ANATOMY. PLATE WAS REMOVED AND SYNTHETIC CABLES USED INSTEAD. 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
    149821 NCB CRVD FEM SHAF PLT 10H210MM IMPLANT, TRAUMA HRS ZIMMER GMBH 3098267 00889024484238

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Male Hospitalization| R SEE H11 NARRATIVE.