BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK LINER

    MDR report key: 22009843 · Received May 13, 2025

    Report

    Report Number
    0001822565-2025-01353
    Event Type
    Injury
    Date Received
    May 13, 2025
    Date of Event
    December 20, 2024
    Report Date
    May 12, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). B3: EVENT DATE IS THE PUBLICATION DATE OF THE ARTICLE. G2: SOBHI S, KOP A, PABBRUWE M, JONES CW, FINSTERWALD MA. INTRAPROSTHETIC DISLOCATION FOLLOWING DUAL MOBILITY TOTAL HIP ARTHROPLASTY: A RETRIEVAL ANALYSIS STUDY. ARTHROPLAST TODAY. 2024 DEC 20;31:101596. DOI: 10.1016/J.ARTD.2024.101596. PMID: 39811773; PMCID: PMC11732184. G2: FOREIGN AUSTRALIA. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. PART AND LOT IDENTIFICATION ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, NEITHER WERE PROVIDED. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THIS COMPLAINT CANNOT BE CONFIRMED. ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION, AND NO FURTHER INFORMATION HAS BEEN PROVIDED 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 THE STUDY PATIENT UNDERWENT AN INITIAL HIP PROCEDURE. THE STUDY REPORTED ONE TOTAL HIP PATIENT EXPERIENCED INTRAPROSTATIC DISLOCATION (DISASSOCIATION) APPROXIMATELY 4 MONTHS POSTOP. A REVISION WAS REQUIRED AFTER UNSUCCESSFUL CLOSED REDUCTION WAS ATTEMPTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2370806 UNK LINER PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female Hospitalization| R