BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX DELTA HEAD 12/14 40X0

    MDR report key: 24977884 · Received April 24, 2026

    Report

    Report Number
    0009613350-2026-00219
    Event Type
    Injury
    Date Received
    April 24, 2026
    Date of Event
    April 15, 2026
    Report Date
    April 24, 2026
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    PMA / PMN Number
    K200112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). G2: FOREIGN - EVENT OCCURRED IN AUSTRALIA. D10: CONCOMITANT MEDICAL PRODUCTS: DESC: G7 OSSEOTI 4 HOLE SHELL 54MM F; ITEM: 110010245; LOT: 67524610. DESC: FEMORAL STEM CEMENTLESS COLLARED STANDARD OFFSET 12/14 TAPER SIZE 3; ITEM: 574201030; LOT: 3210756. DESC:40MM I.D. SIZE F NEUTRAL LINER; ITEM: 30104006; LOT: 67489040. 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

    IT WAS REPORTED THE PATIENT UNDERWENT A HIP REVISION APPROXIMATELY 2 WEEKS POST-IMPLANTATION DUE TO MALPOSITION, INCORRECT SIZING, AND DISLOCATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610200 BIOLOX DELTA HEAD 12/14 40X0 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER LZO ZIMMER GMBH 3264121

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| H SEE H11 NARRATIVE.