BEUDAMED
    FDA Adverse Event Injury Summary report: N

    36MM I.D. SIZE E NEUTRAL LINER

    MDR report key: 23061647 · Received September 16, 2025

    Report

    Report Number
    0001822565-2025-03425
    Event Type
    Injury
    Date Received
    September 16, 2025
    Date of Event
    August 25, 2025
    Report Date
    November 19, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00889024519909
    PMA / PMN Number
    K190660
    Removal / Correction 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: D4; G3; H2; H3; H4; H6; H10. 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. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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 TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: ZB 12/14 COCR HD 36MM X +0. ITEM: 802203602. LOT: 3153671. FEMORAL STEM 12/14 NECK TAPER STANDARD OFFSET SIZE 1 130 MM STEM LENGTH. ITEM: 00811400100. LOT: 66635201. G7 OSSEOTI MULTIHOLE 52MM E. ITEM: 110010264. LOT: 67096600. ALLEN MEDULLARY CEMENT PLUGS 1-28 MM DIAMETER FLANGE/14 MM DIAMETER CORE STORE IN COOL DRY PLACE ITEM: 00801102028. LOT: 66543445. G2: AUSTRALIA. THE CUSTOMER INDICATED THAT THE PRODUCT WILL BE EVALUATED BY EXTERNAL CONTRACTOR; THEREFORE, IT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    DUE DILIGENCE IS COMPLETE AS MULTIPLE ATTEMPTS WERE MADE; HOWEVER, NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP REVISION APPROXIMATELY 4 MONTHS POST-IMPLANTATION DUE TO JOINT DISLOCATION. FOLLOW-UPS TO GATHER ADDITIONAL INFORMATION ARE CURRENTLY IN PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287463 36MM I.D. SIZE E NEUTRAL LINER PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. 66543445 00889024519909

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Required Intervention| H SEE H11.