BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SCREW

    MDR report key: 24685451 · Received March 25, 2026

    Report

    Report Number
    0001825034-2026-00713
    Event Type
    Injury
    Date Received
    March 25, 2026
    Date of Event
    December 5, 2025
    Report Date
    March 25, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: CAT# 110010264; LOT# 66440602; G7 OSSEOTI MULTIHOLE 52MM E. CAT# 110024463; LOT# 67337776; G7 DUAL MOBILITY LINER 42MM E. CAT# 110031011; LOT# 67121610; VIVACIT-E DM BEARING 28X42MM. CAT# 65020073; LOT# 163660; BIOMET MODULAR HEAD -6MM TYPE 1 TAPER 28M. CAT# 51-116110; LOT# 7872145; TPRLC 133 MP TYPE1 BM SO 11.0. UNKNOWN SCREWS (X2). THE REPORTED EVENT COULD NOT BE CONFIRMED DUE TO LACK OF PRODUCT/INFORMATION. ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION, AND NO FURTHER INFORMATION HAS BEEN PROVIDED. VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED THE ACETABULAR COMPONENTS (SHELL, LINER, BEARING, SCREWS AND HEAD) AND STEM HAVE BEEN REVISED AND ARE COVERED IN BIODEBRIS. NO OTHER SIGNIFICANT FINDINGS NOTED ON THE SHELL OR SCREWS FROM THE IMAGE PROVIDED RELATED TO THE REPORTED ISSUES. NO FURTHER OBSERVATIONS CAN BE MADE BASED ON THE IMAGE ALONE. NO PRODUCT WAS RETURNED; FURTHER VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. AS PART AND LOT INFORMATION WAS NOT PROVIDED, A RISK MANAGEMENT FILE CANNOT BE IDENTIFIED AND RISK ASSESSMENT COULD NOT BE PERFORMED. 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 APPROXIMATELY THREE MONTHS POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION DUE TO THE CUP DISSOCIATING FROM THE ACETABULAR WALL. THE CUP WAS NOT SEATED. ALL COMPONENTS WERE REVISED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746629 UNKNOWN SCREW PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R