BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK LINER

    MDR report key: 23509978 · Received November 10, 2025

    Report

    Report Number
    0001825034-2025-03536
    Event Type
    Injury
    Date Received
    November 10, 2025
    Date of Event
    October 19, 2024
    Report Date
    November 20, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: UNK TAPER ADAPTER, UNK SHELL. CAT# 650-1056, LOT# 3111543, CER BIOLOXD OPTION HD 32MM. THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS ITS LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: G3; H2; H6. D4: ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION AND NO FURTHER INFORMATION HAS BEEN PROVIDED. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. DEVICE HISTORY RECORD REVIEW CANNOT BE PERFORMED WITHOUT PRODUCT IDENTIFICATION. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED. A REVIEW OF THE AVAILABLE RECORDS IDENTIFIED FINDINGS OF THE REPORTED ISSUES. REVISION: ALL PRODUCTS EXCEPT STEM REVISED. INDICATION: TWO RECURRENT DISLOCATIONS WITH INSTANT PAIN. ANTERIOR DISLOCATION. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. COMPLAINT IS NOT CONFIRMED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY NINE YEARS POST-IMPLANTATION, THE PATIENT UNDERWENT A RIGHT HIP REVISION DUE TO TWO RECURRENT DISLOCATIONS WITH PAIN. THE STEM WAS RETAINED AND OTHER COMPONENTS REVISED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2436191 UNK LINER PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| H