BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK BEARING

    MDR report key: 22306991 · Received June 23, 2025

    Report

    Report Number
    0001825034-2025-01813
    Event Type
    Injury
    Date Received
    June 23, 2025
    Date of Event
    March 10, 2025
    Report Date
    June 23, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D4: ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION AND NO FURTHER INFORMATION HAS BEEN PROVIDED. D10: CAT: 12-115111 LOT: 2965002 CER BIOLOXD MOD HD 28MM +3 NK, CAT: 00625006530 LOT: 64378436 BONE SCR 6.5X30 SELF-TAP, CAT: 00625006535 LOT: 64383906 BONE SCR 6.5X35 SELF-TAP, CAT: 00625006540 LOT: 64172354 BONE SCR 6.5X40 SELF-TAP, CAT: 192011 LOT: 441380 ECHO POR FMRL NC 11X135MM. 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. 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 THAT APPROXIMATELY FIVE YEARS POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION DUE TO DISLOCATION. A NEW LINER AND HEAD WERE IMPLANTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    926611 UNK BEARING PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| H