BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX DELTA CERAMIC FEM HD 36/+3MM

    MDR report key: 23803521 · Received December 15, 2025

    Report

    Report Number
    3002806535-2025-00622
    Event Type
    Injury
    Date Received
    December 15, 2025
    Date of Event
    November 17, 2025
    Report Date
    May 21, 2026
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    UDI-DI
    00887868271182
    PMA / PMN Number
    K200959
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10 - ASSOCIATED MEDICAL DEVICES: G7 10 DEG E1 LINER 36MM F; ITEM# 010000897; LOT# 6962506. G7 BONEMASTER LTD ACET SHL 56F; ITEM# 010000705; LOT# 6840508. ECHO POR FMRL RED NC 14X150MM; ITEM# 192414; LOT# 737850. G2 - FOREIGN: SPAIN. THE CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: A1, A2, B4, B5, B7, G3, G6, H2, H6, H11. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY FOUR YEARS AND FOUR MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT A REVISION OF A TOTAL HIP REPLACEMENT, AFTER RADIOGRAPHIC FINDINGS SUGGESTED A FEMORAL HEAD FRACTURE. INTRAOPERATIVE ASSESSMENT CONFIRMED THE CERAMIC HEAD FRACTURE AND ASSOCIATED POLYETHYLENE LINER WEAR CAUSED BY LOOSE CERAMIC FRAGMENTS. ALL FRAGMENTS WERE REMOVED, THE LINER WAS DISIMPACTED, AND THE JOINT WAS THOROUGHLY IRRIGATED. THE ACETABULAR CUP WAS INSPECTED AND FOUND TO BE INTACT. A NEW POLYETHYLENE LINER AND HEAD WERE IMPLANTED. A POSSIBLE FALL FROM A BICYCLE WAS REPORTED AS A POTENTIAL CONTRIBUTING FACTOR. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; NO FURTHER INFORMATION OR PRODUCT HAS BEEN RECEIVED AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED A PATIENT HAD AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT REPORTED EXPERIENCING PAIN, AND RADIOGRAPHIC IMAGING DISPLAYED A FRACTURE OF THE CERAMIC HEAD. APPROXIMATELY FOUR YEARS AND FOUR MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT A REVISION SURGERY WHERE THE HEAD WAS FOUND FRACTURED IN HALF WITH FREE FRAGMENTS AND THE INNER POLYETHYLENE LINER WAS FRACTURED WITH THE POSTERIOR INTACT. ALL FRAGMENTS WERE REMOVED, THE LINER WAS DISIMPACTED, AND THE JOINT WAS THOROUGHLY IRRIGATED. THE ACETABULAR CUP WAS INSPECTED AND FOUND TO BE INTACT. A NEW POLYETHYLENE LINER AND HEAD WERE IMPLANTED WITHOUT COMPLICATION. NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106393 BIOLOX DELTA CERAMIC FEM HD 36/+3MM PROSTHESIS, HIP LZO BIOMET UK LTD. 3062846 00887868271182

    Patients

    Seq Age Sex Outcome Treatment
    1