BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5 T-PLT OBL 3H HD 3H SHFT ST

    MDR report key: 23416830 · Received October 29, 2025

    Report

    Report Number
    0001822565-2025-03893
    Event Type
    Injury
    Date Received
    October 29, 2025
    Date of Event
    July 17, 2024
    Report Date
    March 25, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HWC
    UDI-DI
    00889024358522
    PMA / PMN Number
    K101073
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). G2: FOREIGN: UNITED KINGDOM. D10: 3.5MM T-PLATE OBLIQUE 3-HOLE HEAD 3 HOLE SHAFT 52MM LOT 63314774, REF 47-4935-033-05, 3.5MM CORTICAL SCREW SELF-TAPPING 12MM X2, LOT 65492496, REF 47-4835-012-01, 3.5MM CORTICAL SCREW SELF-TAPPING 14MM X2 LOT 65514780, REF 47-4835-014-01, 3.5MM CORTICAL SCREW SELF-TAPPING 14MM X2 LOT 65743325, REF 47-4835-014-01, 3.5MM CORTICAL SCREW SELF-TAPPING 16MM LOT 65514783, REF 47-4835-014-01, 3.5MM CORTICAL SCREW SELF-TAPPING 16MM LOT 65335672, REF 47-4835-016-01, 3.5MM CORTICAL SCREW SELF-TAPPING 18MM LOT 65594032, REF 47-4835-018-01, 3.5MM CORTICAL SCREW SELF-TAPPING 24MM LOT 63390897, REF 47-4835-024-01, 3.5MM CORTICAL SCREW SELF-TAPPING 28MM X2 LOT 65271226, REF 47-4835-028-01, 3.5MM CORTICAL SCREW SELF-TAPPING 28MM LOT 63248494, REF 47-4835-028-01, 3.5MM CORTICAL SCREW SELF-TAPPING 32MM LOT 64773015, REF 47-4835-032-01, 4.0MM CANCELLOUS SCREW FULLY THREADED 14MM LOT 63253949, REF 47-4840-014-00. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B3; D4; H2; H3; H4; H6; H11. 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. MEDICAL RECORDS WERE NOT PROVIDED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FROM A STUDY THAT THE PATIENT REQUIRED REMOVAL OF MEDIAL AND LATERAL PLATES AND SCREWS DUE TO RESTRICTED RANGE OF MOTION (ROM). ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2685720 3.5 T-PLT OBL 3H HD 3H SHFT ST ORTHOPAEDIC FIXATION PLATE, NON-BIOABSORBABLE HWC ZIMMER BIOMET, INC. 63314774 00889024358522

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Hospitalization| R