BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA CER FM HD 036/-4MM 12/14

    MDR report key: 24963065 · Received April 23, 2026

    Report

    Report Number
    3002806535-2026-00158
    Event Type
    Injury
    Date Received
    April 23, 2026
    Date of Event
    April 29, 2025
    Report Date
    April 23, 2026
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    UDI-DI
    00887868271342
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D4: THIS DEVICE IS SOLD OUTSIDE THE US AND THEREFORE NO GUDID INFORMATION EXISTS. THIS DEVICE IS CONSIDERED SIMILAR TO (B)(4). D10: ITEM NAME: G7 PPS LTD ACET SHELL 52E; ITEM NUMBER: 010000663; LOT NUMBER: 7772258. ITEM NAME: TPRLC 133 MP 12/14 BM HO 12.0; ITEM NUMBER: 51-137120; LOT NUMBER: 6493698. ITEM NAME: BIOLOX DELTA CER LNR 36MM E; ITEM NUMBER: 110003634; LOT NUMBER: 3212481. G2 ¿ FOREIGN ¿ POLAND. G4: THE REPORTED PRODUCT IS NOT SOLD IN THE US, THE PRE-MARKET SUBMISSION NUMBER FOR THE SIMILAR PRODUCT SOLD IN THE US IS K082996. 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 TO HIP REVISION SURGERY DUE TO EXPERIENCED PAIN, SNAPPING SENSATION AND CREPITUS. CERAMIC LINER AND HEAD EXCHANGED, CERAMIC HEAD WAS FOUND TO HAVE FRACTURED. APPROXIMATELY 55 DAYS POST-IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND ALL ADDITIONAL INFORMATION RECEIVED HAS BEEN INCLUDED IN THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499336 DELTA CER FM HD 036/-4MM 12/14 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS LZO BIOMET UK LTD. 3223519 00887868271342

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Hospitalization| R SEE H10 NARRATIVE