BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOLOX DELTA CER FEM HD 32/0MM T1

    MDR report key: 23277334 · Received October 15, 2025

    Report

    Report Number
    3002806535-2025-00494
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Date of Event
    September 11, 2025
    Report Date
    March 18, 2026
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    UDI-DI
    00887868271564
    PMA / PMN Number
    K200959
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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, D10, G3, G6, H2, H3, H6, H11. D10: 51-103100, TPRLC 133 T1 PPS SO 10X140MM, LOT 7281528. 010000662, G7 PPS LTD ACET SHELL 50D, LOT 7748725. 110003621, BIOLOX DELTA CER LNR 32MM D, LOT 3211546. COMPLAINT CAN BE CONFIRMED THROUGH THE RETURNED PRODUCT ANALYSIS. VISUAL INSPECTION OF THE RETURNED HEAD CONFIRMED THAT IT HAS FRACTURED. IT EXHIBITS EXTENSIVE DARK MARKS WITHIN THE TAPER HOLE, INCLUDING ON THE FRACTURE PIECE. THE PRESENCE OF THESE MARKS ON THE FRACTURE SURFACE INDICATES THAT THEY WERE PRESENT PRIOR TO THE FRACTURE EVENT. 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) G2 ¿ FOREIGN ¿ CHINA. INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. 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

    IT WAS REPORTED THAT DURING THE SURGERY THE CERAMIC HEAD FRACTURED DURING THE REDUCTION PROCESS, WHILE THE SURGEON FOLLOWED SURGICAL TECHNIQUES. THERE WAS FIVE MINUTES OF DELAY. ALL PIECES WERE REMOVED FROM THE PATIENT. NO FOLLOW-UP WAS PERFORMED AS ALL REQUIRED INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175601 BIOLOX DELTA CER FEM HD 32/0MM T1 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER LZO BIOMET UK LTD. 3157033 00887868271564

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown