BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TORNIER PYROCARBON HUM HEAD DIA 52MMX19MMX1.5MM ECC LO

    MDR report key: 21933337 · Received April 30, 2025

    Report

    Report Number
    3000931034-2025-00233
    Event Type
    Injury
    Date Received
    April 30, 2025
    Date of Event
    April 4, 2025
    Report Date
    July 22, 2025
    Manufacturer
    TORNIER S.A.S.
    Product Code
    KWS
    UDI-DI
    037003886943355
    PMA / PMN Number
    DEN220012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONCE THE INVESTIGATION IS COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT COULD NOT BE CONFIRMED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCES WERE PROVIDED. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. IF THE DEVICE IS RETURNED OR IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED.

    Description of Event or Problem · 0

    PT UNDERWENT LEFT SHOULDER HEMI-ARTHROPLASTY, ON (B)(6) 2018. A PYRO-CARBON HEAD WAS USED INITIALLY. RECENTLY PT HAS BEEN COMPLAINING OF INCREASING DISCOMFORT IN THIS JOINT AND PRESENTED FOR REVIEW. SURGEON PERFORMED A SHOULDER ARTHROSCOPY ON THIS JOINT WITH MILD GLENOID ARTHRITIS NOTED. PT INSISTED ON HAVING A SHOULDER REVISION (GLENOID RESURFACING), EVEN THOUGH SURGEON RECOMMENDED MORE CONSERVATIVE MANAGEMENT (ORAL ANALGESICS). DURING SURGERY, MILD GLENOID ARTHRITIC CHANGES WERE NOTED, AND SURGEON DECIDED TO GO AHEAD, AS PER PATIENT'S WISHES, AND RESURFACE THE GLENOID - A POLY GLENOID PROSTHESIS WAS IMPLANTED. PYROCARBON HEAD REPLACED WITH A METAL HEAD, AS THE PYC HEAD IS NOT INDICATED FOR USE WITH A POLY GLENOID COMPONENT. JOINT STABLE AFTER REDUCTION. WOUND CLOSED.

    Description of Event or Problem · 0

    PT UNDERWENT LEFT SHOULDER HEMI-ARTHROPLASTY, ON (B)(6) 2018. A PYRO-CARBON HEAD WAS USED INITIALLY. RECENTLY PT HAS BEEN COMPLAINING OF INCREASING DISCOMFORT IN THIS JOINT AND PRESENTED FOR REVIEW. SURGEON PERFORMED A SHOULDER ARTHROSCOPY ON THIS JOINT WITH MILD GLENOID ARTHRITIS NOTED. PT INSISTED ON HAVING A SHOULDER REVISION (GLENOID RESURFACING), EVEN THOUGH SURGEON RECOMMENDED MORE CONSERVATIVE MANAGEMENT (ORAL ANALGESICS). DURING SURGERY, MILD GLENOID ARTHRITIC CHANGES WERE NOTED, AND SURGEON DECIDED TO GO AHEAD, AS PER PATIENT'S WISHES, AND RESURFACE THE GLENOID - A POLY GLENOID PROSTHESIS WAS IMPLANTED. PYROCARBON HEAD REPLACED WITH A METAL HEAD, AS THE PYC HEAD IS NOT INDICATED FOR USE WITH A POLY GLENOID COMPONENT. JOINT STABLE AFTER REDUCTION. WOUND CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1413123 TORNIER PYROCARBON HUM HEAD DIA 52MMX19MMX1.5MM ECC LO PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED KWS TORNIER S.A.S. 6418AS 037003886943355

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Required Intervention