BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX DELTA MODULAR CER FEM HD 28/-3MM T1

    MDR report key: 21804812 · Received April 9, 2025

    Report

    Report Number
    3002806535-2025-00153
    Event Type
    Injury
    Date Received
    April 9, 2025
    Date of Event
    March 24, 2025
    Report Date
    August 22, 2025
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    PMA / PMN Number
    K192683
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 110031012, 28MM I.D. 44MM O.D. SIZE F BEARING, LOT 65461985. 650-1066, CER OPT TYPE 1 TPR SLEVE 0MM, LOT 3163185. 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H2, H3, H6, H11. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; A PRODUCT EVALUATION COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. REVIEW OF THE COMPLAINT HISTORY IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEM AND NO ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED PART AND LOT COMBINATION. BASED ON THE AVAILABLE INFORMATION, THE REPORTED EVENT CANNOT BE CONFIRMED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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 THE PATIENT UNDERWENT RIGHT HIP REVISION SURGERY TWO YEARS POST INITIAL IMPLANTATION DUE TO DISLOCATION. THE HEAD AND LINER WERE REPLACED. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471324 BIOLOX DELTA MODULAR CER FEM HD 28/-3MM T1 HIP PROTHESIS LZO BIOMET UK LTD. 3090772

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| R SEE H11 NARRATIVE.