BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX DELTA CER OPTION HD 36MM

    MDR report key: 24697386 · Received March 26, 2026

    Report

    Report Number
    3002806535-2026-00132
    Event Type
    Injury
    Date Received
    March 26, 2026
    Date of Event
    April 7, 2024
    Report Date
    March 26, 2026
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    UDI-DI
    00880304521957
    PMA / PMN Number
    K200959
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10 - ASSOCIATED MEDICAL DEVICES: CER OPTION TYPE 1 TPR SLEVE -6; ITEM# 650-1064; LOT# 2900787. G7 FINNED 3 HOLE SHELL 50D; ITEM# 110017102; LOT# 6248681. G7 NEUTRAL E1 LINER 36MM D; ITEM# 010000856; LOT# 6281670. TLOC 133 MP SP T1 PPS HO 8X101; ITEM# 51-109080; LOT# 3590303. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, APPROXIMATELY FIVE YEARS AND TEN MONTHS POST-IMPLANTATION, THE PATIENT EXPERIENCED LEFT ANTERIOR HIP PAIN OF UNKNOWN ORIGIN, WITH NO FALL OR TRAUMA REPORTED. IMAGING DID NOT DEMONSTRATE ANY PROSTHETIC ISSUES, AND MEDICATION WAS PRESCRIBED. UPON FURTHER FOLLOW-UP, THE PATIENT REMAINS IN THE STUDY, AND ALL INITIAL COMPONENTS ARE STILL RETAINED. NO ADDITIONAL DETAILS HAVE BEEN PROVIDED AT THIS TIME. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759747 BIOLOX DELTA CER OPTION HD 36MM PROSTHESIS, HIP LZO BIOMET UK LTD. 2904517 00880304521957

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other SEE H11 NARRATIVE.