BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN TORNIER PERFORM HUMERAL IMPLANT

    MDR report key: 25229464 · Received May 20, 2026

    Report

    Report Number
    0001649390-2026-00469
    Event Type
    Injury
    Date Received
    May 20, 2026
    Date of Event
    May 1, 2022
    Report Date
    May 20, 2026
    Manufacturer
    TORNIER INC
    Product Code
    PAO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT HAS BEEN GENERATED BASED ON FINDINGS IDENTIFIED DURING POST MARKET SURVEILLANCE LITERATURE. THE ARTICLE CAN BE FOUND AT HTTPS://DOI.ORG/10.1016/J.JSEINT.2025.06.016 THE REPORTED EVENT COULD NOT BE CONFIRMED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER ADDITIONAL INFORMATION WAS RECEIVED FROM THE AUTHOR. MORE DETAILED INFORMATION ABOUT THE PATIENT'S MEDICAL HISTORY, THE EVENT DETAILS AND THE INVOLVED DEVICE(S) MUST BE AVAILABLE TO DETERMINE THE ROOT CAUSE. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THE INVESTIGATION WILL BE REOPENED AND RE-EVALUATED ACCORDINGLY.

    Description of Event or Problem · 0

    THE MANUFACTURER BECAME AWARE OF A LITERATURE PUBLISHED BY DR MOVERMAN FROM DEPARTMENT OF ORTHOPAEDIC SURGERY, UNIVERSITY OF UTAH, THE TITLE OF THIS ARTICLE IS "TWO-YEAR FUNCTIONAL AND RADIOGRAPHIC OUTCOMES OF A CONVERTIBLE METAPHYSEAL-BASED SHORT HUMERAL STEM IN ANATOMIC SHOULDER ARTHROPLASTY: A COMPARISON TO STEMLESS HUMERAL COMPONENTST", PUBLISHED IN 2025, WHICH IS ASSOCIATED WITH THE TORNIER PERFORM HUMERAL SYSTEM. THE ARTICLE CAN BE FOUND ON HTTPS://DOI.ORG/10.1016/J.JSEINT.2025.06.016 DURING THE REVIEW OF THE LITERATURE, IT WAS NOT POSSIBLE TO ESTABLISH A SPECIFIC DEVICE DETAIL, PATIENT INFORMATION, AND AT THIS TIME NO ADDITIONAL DEVICE INFORMATION IS AVAILABLE. IT WAS REPORTED THAT: THERE WERE 3 PATIENTS IN THE STEMMED GROUP THAT UNDERWENT SUCCESSFUL REVISION LTO FIXATION FOR LTO DISPLACEMENT. ALL LTO FAILURES OCCURRED IN THE SETTING OF TRAUMA OR SLING NONCOMPLIANCE. A CORRECTIVE SOFT TISSUE PROCEDURE TO ADDRESS A FAILED LTO FIXATION. THIS IS PATIENT 2 OUT OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421337 UNKNOWN TORNIER PERFORM HUMERAL IMPLANT PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER + ADDITIVE, CEMENTED PAO TORNIER INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1