BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    UNK LINER

    MDR report key: 23232559 · Received October 7, 2025

    Report

    Report Number
    0001822565-2025-03667
    Event Type
    Injury
    Date Received
    October 7, 2025
    Date of Event
    January 24, 2025
    Report Date
    May 6, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    003

    Narratives

    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, H6, H11. CORRECTED: D2B. THE REPORTED EVENT COULD NOT BE CONFIRMED DUE TO LACK OF PRODUCT/EVENT INFORMATION. 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. COMPLAINT HISTORY REVIEW CANNOT BE PERFORMED WITHOUT PRODUCT IDENTIFICATION. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). B3: PUBLICATION DATE. D10: UNK HEAD UNKNOWN. G2: FOREIGN: SWEDEN. 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. REFERENCE: MICHAEL AXENHUS, GHAZI CHAMMOUT, PAULA KELLY-PETTERSSON, SEBASTIAN MUKKA, MARTIN MAGNÉLI, OLOF SKÖLDENBERG LONG-TERM OUTCOMES OF CEMENTED COMPARED TO UNCEMENTED FEMORAL STEMS IN TOTAL HIP ARTHROPLASTY FOR DISPLACED FEMORAL NECK FRACTURES IN ELDERLY PATIENTS EUROPEAN JOURNAL OF TRAUMA AND EMERGENCY SURGERY (2025) 51:73HTTPS://DOI.ORG/10.1007/S00068-024-02735-0.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT WAS OBTAINED PROVIDED THAT THE PURPOSE OF THE STUDY WAS TO ASSESS LONG-TERM OUTCOME OF CEMENTED AND UNCEMENTED STEM RESULTS. THE STUDY REVIEWED 69 PATIENTS WITH DISPLACED FEMORAL NECK FRACTURES. ALL SURGERIES WERE PERFORMED USING DIRECT LATERAL APPROACH WITH THE PATIENT IN THE LATERAL DECUBI¬TUS POSITION, PATIENTS WERE SPLIT INTO 2 GROUPS; CEMENTED GROUP RECEIVED THE MODULAR CPT (ZIMMER, WARSAW, INDIANA, USA) AND THE UNCEMENTED GROUP RECEIVED THE BI-METRIC STEM (BIOMET, WARSAW, INDIANA, USA). THE STUDY POPULATION HAD A MEAN AGE OF 73 YEARS AT TIME OF SURGERY; (NUMBER OF 22 MALES/47 FEMALES). FOLLOW-UP WAS CONDUCTED AT 3, 12, 24 MONTHS, AND AT 4 AND 10 YEARS AFTER THE SURGERY. COMPLAINT 1: THE STUDY REPORTED ONE PATIENT WITHIN THE CEMENTED GROUP WITH A DISLOCATION RESULTING IN A CLOSED REDUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369095 UNK LINER PROSTHESIS, HIPS LPH ZIMMER BIOMET, INC. N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H SEE H11 NARRATIVE.