BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XLPE 10 DEG POLY LINER 58X36

    MDR report key: 22783295 · Received August 12, 2025

    Report

    Report Number
    0001822565-2025-02891
    Event Type
    Injury
    Date Received
    August 12, 2025
    Date of Event
    March 23, 2012
    Report Date
    August 27, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K002960
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 142-36-00 EXACTECH COCR FEM HEAD 36MM +0 OFFSET UNK. 160-70-15 NV CEMENTED PLUS STD SIZE 15 UNK. 6202-58-20 TRABECULAR METAL MODULAR ACETABULAR SYSTEM UNK. 4894-050-10 ACETABULAR AUGMENT UNK. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. LOT IDENTIFICATION IS NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS; LOT IDENTIFICATION WAS NOT PROVIDED. MEDICAL RECORDS WERE NOT PROVIDED. IT WAS IDENTIFIED THAT ZIMMER BIOMET DEVICES WERE IMPLANTED WITH COMPETITOR DEVICES. ZIMMER BIOMET HAS NOT CONFIRMED THE COMPATIBILITY FOR THESE COMBINATIONS OF DEVICES. IT IS UNKNOWN IF THESE OFF-LABEL USAGES MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENTS. A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED. PER IFU, TRILOGY ACETABULAR SYSTEM, IT STATES ONLY AUTHORIZED COMBINATIONS SHOULD BE USED. THIS COMPLAINT CANNOT BE CONFIRMED. 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). THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING FIELDS HAVE BEEN UPDATED: B4, G3, G6, H2, H3, H11. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. LOT IDENTIFICATION IS NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, LOT IDENTIFICATION WAS NOT PROVIDED. THE REPORTED PRODUCTS WERE REVIEWED FOR COMPATIBILITY AND IT WAS DETERMINED THAT THE FOLLOWING IMPLANTS ARE NOT COMPATIBLE: EXACTECH HEAD. REVIEW OF COMPLAINT HISTORY IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEM. HOWEVER, AS THE LOT NUMBER IS UNKNOWN, AN ADDITIONAL REVIEW COULD NOT BE PERFORMED. IT WAS IDENTIFIED THAT ZIMMER BIOMET DEVICES WERE IMPLANTED WITH COMPETITOR DEVICES. ZIMMER BIOMET HAS NOT CONFIRMED THE COMPATIBILITY FOR THESE COMBINATIONS OF DEVICES. IT IS UNKNOWN IF THESE OFF-LABEL USAGES MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENTS. A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED. PER IFU, TRILOGY ACETABULAR SYSTEM, IT STATES ONLY AUTHORIZED COMBINATIONS SHOULD BE USED. THIS COMPLAINT CANNOT BE CONFIRMED. 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 DURING EXAMINATION OF THE PATIENT, AN INCIDENTAL LEFT HIP DISLOCATION OCCURRED. THE PATIENT WAS TAKEN TO SURGERY AND THE PATIENT¿S HIP WAS RELOCATED BY A CLOSED REDUCTION.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2413418 XLPE 10 DEG POLY LINER 58X36 PROSTHESIS, HIPS LPH ZIMMER BIOMET, INC. N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other SEE H11 NARRATIVE