BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX DELTA CER OPTION HD 40MM

    MDR report key: 23742430 · Received December 8, 2025

    Report

    Report Number
    3002806535-2025-00566
    Event Type
    Injury
    Date Received
    December 8, 2025
    Date of Event
    September 21, 2019
    Report Date
    May 28, 2026
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    UDI-DI
    00887868271403
    PMA / PMN Number
    K200959
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10 - ASSOCIATED MEDICAL DEVICES: CER OPTION TYPE 1 TPR SLEVE -6; ITEM# 650-1064; LOT# 843540. G7 FINNED 4 HOLE SHELL 54F; ITEM# 110017104; LOT# 3737138. G7 HI-WALL E1 LINER 40MM F; ITEM# 010000942; LOT# 3722429. TPRLC 133 T1 PPS SO 10X140MM; ITEM# 51-103100; LOT# 3216783. UNKNOWN G7 BONE SCREW 6.5X25; ITEM# UNKNOWN; LOT# UNKNOWN. 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 APPROXIMATELY 3 YEARS AND 5 MONTHS POST AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY, THE PATIENT REPORTED EXPERIENCING MODERATE PAIN AND REQUIRED CANES FOR AMBULATION. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; NO FURTHER ADDITIONAL INFORMATION HAS BEEN RECEIVED AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318318 BIOLOX DELTA CER OPTION HD 40MM PROSTHESIS, HIP LZO BIOMET UK LTD. 771480 00887868271403

    Patients

    Seq Age Sex Outcome Treatment
    1