BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI LOW PROFILE SCREW 6.5X15MM

    MDR report key: 23281242 · Received October 15, 2025

    Report

    Report Number
    0001825034-2025-03201
    Event Type
    Injury
    Date Received
    October 15, 2025
    Date of Event
    July 12, 2011
    Report Date
    January 7, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K082446
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 103531 TI LOW PROFILE SCREW 6.5X20MM (B)(6). 103535 TI LOW PROFILE SCREW 6.5X40MM (B)(6). 12-104152 M/H RADIAL 3-HOLE SHELL 52MM (B)(6). G2: FOREIGN: CANADA. 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: B4, B5, G3, G6, H2, H3, H4, H6, H11 NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED ISSUES FOR THESE ITEMS AND THE REPORTED PART AND LOT COMBINATIONS. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: ¿ DIAGNOSIS - LOOSENING OF TOTAL LEFT HIP PROSTHESIS WITH FRACTURE OF THE ACETABULUM 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 A PATIENT HAD AN INITIAL LEFT TOTAL HIP ARTHROPLASTY WHICH WAS REVISED DUE TO ASEPTIC LOOSENING OF THE ACETABULAR COMPONENT FOLLOWING A FALL. THE PATIENT WAS REVISED AGAIN DUE TO LOOSENING AND ACETABULAR FRACTURE. DURING THE REVISION, THE ACETABULAR COMPONENTS WERE REMOVED, AND PUTTY WAS USED TO MITIGATE THE BONE DEFECTS. THE INITIAL STEM WAS RETAINED. NO INTRAOP COMPLICATIONS WERE IDENTIFIED.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187183 TI LOW PROFILE SCREW 6.5X15MM PROSTHESIS, HIPS KWA ZIMMER BIOMET, INC. N/A 852200

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| R SEE H11 NARRATIVE.