BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 VIT E NEUTRAL LNR 36MM D

    MDR report key: 24547669 · Received March 9, 2026

    Report

    Report Number
    0001822565-2026-00761
    Event Type
    Injury
    Date Received
    March 9, 2026
    Date of Event
    February 12, 2026
    Report Date
    March 9, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00889024519893
    PMA / PMN Number
    K190660
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: IG7 OSSEOTI MULTIHOLE ACET SHE LL 50MM D. ITEM: 1100102631. LOT: 67269038. BIOLOX® DELTA, CERAMIC FEMORAL HEAD, S, ø 36/-3.5, TAPER 12/14. ITEM: 00877503601. LOT: 3232920. BONE SCREW SELF-TAPPING 6.5 MM DIA. 20 MM LENGTH. ITEM: 00625006520. LOT: J7941442. G2: FOREIGN ¿ JAPAN. THE CUSTOMER INDICATED THAT THE PRODUCT WAS DISCARDED; THEREFORE, IT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP REVISION APPROXIMATELY ONE-YEAR POST IMPLANTATION DUE TO THE LINER¿S LOCKING MECHANISM FAILING. THE LINER WAS REVISED. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610766 G7 VIT E NEUTRAL LNR 36MM D PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. 67260377 00889024519893

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H