BEUDAMED
    FDA Adverse Event Injury Summary report: N

    28MM I.D. 38MM O.D. SIZE C BEARING

    MDR report key: 24380088 · Received February 18, 2026

    Report

    Report Number
    0001825034-2026-00382
    Event Type
    Injury
    Date Received
    February 18, 2026
    Date of Event
    October 1, 2025
    Report Date
    February 18, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00889024572676
    PMA / PMN Number
    K190656
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). G2 - FOREIGN: AUSTRALIA. THE REPORTED EVENT COULD NOT BE CONFIRMED DUE TO LACK OF PRODUCT/INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. THE ROOT CAUSE OF THE REPORTED INFECTION WAS DETERMINED TO BE UNRELATED TO THE DEVICE. REVIEW OF THE REPORTED EVENT BY A HEALTH CARE PROFESSIONAL FOUND: THE REPORTED EVENT OF DEEP/UNSPECIFIED INFECTION OCCURRED <90 DAYS POST IMPLANTATION. DURING THE INVESTIGATION PROCESS A REVIEW OF THE STERILE CERTIFICATIONS WERE REVIEWED AND FOUND TO BE CONFORMING WITH NO APPLICABLE DEVIATIONS. DEVICES WERE VERIFIED TO HAVE GONE THROUGH ACCEPTABLE STERILIZATION PROCESS FOLLOWING ISO/AAMI/ASTM & EU PUBLISHED GUIDELINES. THERE ARE MULTIPLE FACTORS THAT MAY CONTRIBUTE TO AN INFECTION THAT ARE OUTSIDE THE CONTROL OF ZIMMER BIOMET, SUCH AS EXTERNAL FACTORS, I.E. HOSPITAL/SURGICAL ENVIRONMENT, PROVIDER-RELATED RISK FACTORS, AND/OR PATIENT COMORBIDITIES/RISK FACTORS. AS THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUES IDENTIFIED AFFECTING IMPLANT SAFETY OR EFFECTIVENESS, THEREFORE IMPLANTED PRODUCTS ARE NOT IDENTIFIED AS THE SOURCE OR CONTRIBUTING TO THE REPORTED INFECTION. IT WAS IDENTIFIED THAT ZIMMER BIOMET BEARING WAS IMPLANTED WITH A COMPETITOR LINER. ZIMMER BIOMET HAS NOT CONFIRMED THE COMPATIBILITY FOR THESE COMBINATIONS OF DEVICES. PLEASE NOTE, PER THE IFU 87-6200-021-99 EN REV. B DUAL MOBILITY LONGEVITY® AND VIVACIT-E® POLYETHYLENE HIP BEARINGS, IT STATES NOT TO USE THESE PRODUCTS FOR OTHER THAN LABELLED INDICATIONS (NO OFF-LABEL USE), " DO NOT USE THE DUAL MOBILITY LONGEVITY AND VIVACIT-E POLYETHYLENE HIP BEARINGS WITH COMPONENTS OF ANY OTHER SYSTEM OR MANUFACTURER, UNLESS AUTHORIZED BY ZIMMER BIOMET.¿ IT ALSO STATES ¿ZIMMER BIOMET OR ITS AFFILIATES ARE NOT LIABLE FOR COMPLICATIONS AND/OR FAILURE THAT MAY ARISE FROM USE OF THE DEVICE IN CIRCUMSTANCES OUTSIDE OF ZIMMER BIOMET¿S OR ITS AFFILIATES CONTROL INCLUDING, BUT NOT LIMITED TO, PRODUCT SELECTION AND DEVIATIONS FROM THE DEVICE¿S INDICATED USES OR SURGICAL TECHNIQUE." 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 THAT THE PATIENT UNDERWENT A HIP ARTHROPLASTY AND WAS SUBSEQUENTLY REVISED APPROXIMATELY 3 WEEKS POST-IMPLANTATION DUE TO INFECTION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124505 28MM I.D. 38MM O.D. SIZE C BEARING PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. 67286444 00889024572676

    Patients

    Seq Age Sex Outcome Treatment
    1