BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIVACIT-E DM BEARING 28X44MM

    MDR report key: 25316153 · Received May 28, 2026

    Report

    Report Number
    0001822565-2026-01698
    Event Type
    Injury
    Date Received
    May 28, 2026
    Date of Event
    May 4, 2026
    Report Date
    May 28, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K190656
    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: G7 DUAL MOBILITY LINER 44MM F ITEM: 110024464 LOT: 739070. DELTA CER FEM HD 28/-3MM T1 ITEM: 650-1159 LOT: 3090670. TPRLC 133 FP TYPE1 PPS SO 6.0 ITEM: 51-100060 LOT: 51-100060. G7 OSSEOTI 4 HOLE SHELL 54MM F ITEM: 110010245 LOT: 65300582. BONE SCREW SELF-TAPPING 6.5 MM DIA. 20 MM LENGTH ITEM: 00625006520 LOT: 65292772. THE PRODUCT WAS REQUESTED BUT WAS NOT RETURNED BY THE HOSPITAL AND WILL THEREFORE NOT BE SENT 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 G7 DUAL MOBILITY HIP REVISION DUE TO DISLOCATION. IT WAS CONFIRMED THAT NO FURTHER INFORMATION COULD BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132417 VIVACIT-E DM BEARING 28X44MM PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. 65254637

    Patients

    Seq Age Sex Outcome Treatment
    1