BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CER BIOLOXD OPTION HD 32MM

    MDR report key: 23906270 · Received December 29, 2025

    Report

    Report Number
    3002806535-2025-00678
    Event Type
    Injury
    Date Received
    December 29, 2025
    Date of Event
    September 22, 2016
    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: 650-1065; LOT: 980920. 32MM I.D. SIZE GG ELEVATED RIM LINER USE WITH 48MM O.D. SIZE GG SHELL; ITEM: 00875200832; LOT: 63225292. BONE SCREW SELF-TAPPING 6.5 MM DIA. 40 MM LENGTH; ITEM: 00625006540; LOT: 63289719. BONE SCREW SELF-TAPPING 6.5 MM DIA. 20 MM LENGTH; ITEM: 00625006520; LOT: 63296125N. 48MM O.D. SIZE GG POROUS UNCEMENTED WITH MULTI-HOLES SHELL USE WITH GG LINERS; ITEM: 00875704802; LOT: 62990313. BONE SCREW SELF-TAPPING 6.5 MM DIA. 25 MM LENGTH; ITEM: 00625006525; LOT: 63196736. BONE SCREW SELF-TAPPING 6.5 MM DIA. 20 MM LENGTH; ITEM: 00625006520; LOT: 63272712N. TAPERLOC STEM; ITEM: 14-13200; LOT: 604300. 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 1-MONTH POST IMPLANTATION DUE TO DISLOCATION. DURING THE REVISION, NOTED PERIPROSTHETIC FRACTURE OF THE PELVIS POSTERIORLY TO THE ACETABULUM INCLUDING THE ACETABULAR ROOF. AN OLD PSEUDOTUMOR WAS EXCISED. THE FRACTURE IS REPAIRED USING A PLATE, SCREWS, BONE CEMENT ALONG WITH A SHELL, HEAD, AND TAPER ADAPTER WITHOUT COMPLICATIONS. IT WAS CONFIRMED THAT NO FURTHER INFORMATION COULD BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375962 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