BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOLOX DELTA CER LNR 36MM E

    MDR report key: 24267193 · Received February 5, 2026

    Report

    Report Number
    3002806535-2026-00068
    Event Type
    Malfunction
    Date Received
    February 5, 2026
    Date of Event
    January 22, 2026
    Report Date
    February 5, 2026
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    UDI-DI
    00887868271144
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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 00889024519848. G2: FOREIGN - EVENT OCCURRED IN AUSTRIA. G4: THE REPORTED PRODUCT IS NOT SOLD IN THE US, THE PRE-MARKET SUBMISSION NUMBER FOR THE SIMILAR PRODUCT SOLD IN THE US IS K190660. THE CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING IMPLANTATION, THE CERAMIC INLAY CRACKED WHEN BEING INSERTED. INTRA-OPERATIVELY, THE SURGEON INDICATED THE INLAY WAS POSITIONED CORRECTLY AND THAT A 36 MM INSERTER WAS USED, MATCHED TO THE CORRESPONDING CUP SIZE. THE DURATION OF THE SURGERY WAS EXTENDED BY APPROXIMATELY 10 MINUTES. NO HEALTH IMPACT TO THE PATIENT WAS REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440039 BIOLOX DELTA CER LNR 36MM E PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS LZO BIOMET UK LTD. 3248778 00887868271144

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown