BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACE SHELL-CLUST HOLE POR-48MM IMPLANT

    MDR report key: 24267957 · Received February 5, 2026

    Report

    Report Number
    3005985723-2026-00052
    Event Type
    Injury
    Date Received
    February 5, 2026
    Date of Event
    January 9, 2026
    Report Date
    February 5, 2026
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OQG
    UDI-DI
    00848486008345
    PMA / PMN Number
    K112802
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: CAT# 186132-48; DEVICE DESCRIPTION: ACE LINR-E-POLY NEUT-32/48 IMPLANT; LOT# 191531-01 IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    SURGEON PERFORMED A FULL IMPLANT EXTRACTION AND I&D OF A RIGHT HIP DUE TO INFECTION. SURGEON IMPLANTED AN EXETER CUP AND STEM AS AN ANTIBIOTIC SPACER. REVISION, INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327543 ACE SHELL-CLUST HOLE POR-48MM IMPLANT HIP PROSTHESIS, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER, + ADDITIVE, POROUS, OQG MAKO SURGICAL CORP. 031537-01 00848486008345

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Hospitalization| R