BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CER BIOLOXD OPTION HD 32MM

    MDR report key: 23904916 · Received December 29, 2025

    Report

    Report Number
    3002806535-2025-00668
    Event Type
    Injury
    Date Received
    December 29, 2025
    Date of Event
    July 14, 2017
    Report Date
    May 28, 2026
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    UDI-DI
    00887868248573
    PMA / PMN Number
    K082996
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10. CER OPTION TYPE 1 TPR SLEVE -3; ITEM NUMBER# 650-1065; LOT NUMBER# 980920. TAPERLOC STEM; ITEM NUMBER# 14-13200; LOT NUMBER# 604300. 32MM I.D. SIZE GG ELEVATED RIM LINER USE WITH 48MM O.D. SIZE GG SHELL; ITEM NUMBER# 00875200832; LOT NUMBER# 630203144. SCREWS PLUS RINGS; ITEM NUMBER# UNKNOWN; LOT NUMBER# UNKNOWN; QTY: 2. 10 HOLE PLATE; ITEM NUMBER# UNKNOWN; LOT NUMBER# UNKNOWN. SCREWS; ITEM NUMBER# UNKNOWN; LOT NUMBER# UNKNOWN; QTY: 7. G2: FOREIGN - EVENT OCCURRED IN CANADA. 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 A LEFT HIP REVISION APPROXIMATELY 5-MONTHS POST IMPLANTATION DUE TO DISLOCATION AND NOTED THE PATIENT HAS BEEN FALLING DUE TO UNKNOWN CAUSE. DURING THE REVISION IT WAS NOTED THE ACETABULUM WAS LOOSE, SYNOVITIS, SCREW FRACTURES AND SIGNIFICANT DAMAGE TO THE BONE STRUCTURES OF THE PELVIS WITH THE ENTIRE POSTERIOR-SUPERIOR ROOF IS VIRTUALLY ABSENT AND FRAGMENTED. THE SHELL, LINER, HEAD, TAPER ADAPTER, PLATE, SCREWS, AND ZIMMER FRAME ARE EXCHANGED WITH COMPETITOR ACETABULAR CONSTRUCT AND ALLOGRAFT. IT WAS CONFIRMED THAT NO FURTHER INFORMATION COULD BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99497 CER BIOLOXD OPTION HD 32MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED LZO BIOMET UK LTD. 007000 00887868248573

    Patients

    Seq Age Sex Outcome Treatment
    1