BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MS-30 STEM LATERAL POLISHED 6

    MDR report key: 23829914 · Received December 17, 2025

    Report

    Report Number
    0009613350-2025-00955
    Event Type
    Injury
    Date Received
    December 17, 2025
    Date of Event
    November 25, 2025
    Report Date
    April 7, 2026
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    UDI-DI
    00889024592360
    Adverse Event
    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: A3, B4, G3, G6, H2, H3, H6, H11. THE REPORTED EVENT COULD NOT BE CONFIRMED DUE TO LACK OF PRODUCT/INFORMATION. THE PRODUCT INVOLVED IN THE REPORTED EVENT WAS NOT RETURNED FOR INVESTIGATION; HOWEVER, PICTURES WERE PROVIDED AND REVIEWED. VISUAL EXAMINATION OF PROVIDED PICTURE IDENTIFIED A STEM COVERED WITH BLOOD AND STILL ASSEMBLED TO THE HEAD AND LINER. NOTHING FURTHER CAN BE GAINED REGARDING THE REPORTED EVENT FROM THE PHOTO. 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

    CMP-1022813 D10. NCB®, LOCKING CAP ITEM# 0202150300 LOT# 3213735. NCB®, LOCKING CAP ITEM# 0202150300 LOT# 3226092 (X4). NCB®, LOCKING CAP ITEM# 0202150300 LOT# 3226089. KIRSCHNER WIRE WITH TROCAR TIP, 2 MM, 280 MM ITEM# 29020280 LOT# UNKNOWN. NCB®, PERIPROSTHETIC FEMUR PLATE, PROXIMAL, LEFT, 15 HOLES, 324 MM ITEM# 0202263115 LOT# 3156579. NCB®, PERIPROSTHETIC FEMUR PLATE, PROXIMAL, LEFT, 18 HOLES, 363 MM ITEM# 0202263118 LOT# 3156586. NCB®, SCREW, 5.0, 55 MM ITEM# 0203150055 LOT# UNKNOWN. NCB®, SCREW, 5.0, 38 MM ITEM# 0203150038 LOT# UNKNOWN. NCB®, SCREW, 5.0, 40 MM ITEM# 0203150040 LOT# UNKNOWN. NCB®, SCREW, 5.0, 22 MM ITEM# 0203150022 LOT# UNKNOWN. NCB®, SCREW, 5.0, 32 MM ITEM# 0203150032 LOT# UNKNOWN. NCB®, SCREW, 5.0, 36 MM ITEM# 0203150036 LOT# UNKNOWN. NCB®, SCREW, 5.0, 38 MM ITEM# 0203150038 LOT# UNKNOWN. NCB®, SCREW, 5.0, 40 MM ITEM# 0203150040 LOT# UNKNOWN. NCB®, SCREW, 5.0, 48 MM ITEM# 0203150048 LOT# UNKNOWN. NCB®, SCREW, 5.0, 42 MM ITEM# 0203150042 LOT# UNKNOWN. NCB®, LOCKING CAP ITEM# 0203150300 LOT# UNKNOWN. G2: FOREIGN - EVENT OCCURRED IN 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

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

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT FELL AND SUSTAINED A FEMORAL FRACTURE APPROXIMATELY 3 MONTHS POST-IMPLANTATION. THE PATIENT UNDERWENT EXPLANT OF THE DEVICE. DUE DILIGENCE IS IN PROCESS AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194235 MS-30 STEM LATERAL POLISHED 6 PROSTHESIS, HIP LZO ZIMMER GMBH 3198837 00889024592360

    Patients

    Seq Age Sex Outcome Treatment
    1