BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX DELTA CER FEM HD 28/0MM T1

    MDR report key: 22826403 · Received August 18, 2025

    Report

    Report Number
    3002806535-2025-00348
    Event Type
    Injury
    Date Received
    August 18, 2025
    Date of Event
    July 18, 2025
    Report Date
    December 5, 2025
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    PMA / PMN Number
    K200959
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D4, G3, G6, H2, H3, H4, 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.

    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. THE REPORTED EVENT WAS CONFIRMED BY REVIEW OF PICTURES. THE PRODUCT INVOLVED IN THE REPORTED EVENT WAS NOT RETURNED FOR INVESTIGATION; HOWEVER, PICTURES WERE PROVIDED AND REVIEWED. THE DELTA FEMORAL CERAMIC HEAD APPEARS INTACT, WITH NO VISIBLE DAMAGE OTHER THAN SIGNIFICANT METAL TRANSFER ON THE SPHERICAL SURFACE. THIS TRANSFER IS MOST LIKELY DUE TO CONTACT WITH METAL COMPONENTS FOLLOWING THE DISLOCATION. THE TAPER SHOWS CIRCUMFERENTIAL WITNESS MARKS CONSISTENT WITH ASSEMBLY ONTO THE HIP PROSTHESIS TAPER. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. 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. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). D10 ¿ (B)(6), ACT ARTIC E1 HIP BRG 28X38MM, LOT 902410. G2 ¿ FOREIGN ¿ JAPAN. 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

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

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT HIP REVISION SURGERY APPROXIMATELY EIGHT YEARS POST-IMPLANTATION DUE TO DISLOCATION. DURING THE PROCEDURE, THE BEARING AND HEAD WERE REPLACED. IT WAS ALSO NOTED THAT THE BEARING WAS DAMAGED. NO ADDITIONAL INFORMATION IS AVAILABLE FOR THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1741106 BIOLOX DELTA CER FEM HD 28/0MM T1 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER LZO BIOMET UK LTD. 2015020327

    Patients

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