BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TESS HUM CENTRED HEAD 52MM

    MDR report key: 18317772 · Received December 13, 2023

    Report

    Report Number
    3006946279-2023-00107
    Event Type
    Injury
    Date Received
    December 13, 2023
    Date of Event
    June 1, 2016
    Report Date
    February 19, 2025
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    PHX
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10 - MEDICAL DEVICES: TESS GLENOID CEMENTED PE S3; ITEM# P1700426; LOT# UNKNOWN. TESS HUM ANATOMICAL COROLLA S3; ITEM# P1700446; LOT# UNKNOWN. TESS HUM STEM SMALL; ITEM# P1700128; LOT# UNKNOWN. G2 - FOREIGN: FRANCE. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3006946279-2023-00106, 3006946279-2023-00108, 3006946279-2023-00109. THE PRODUCTS REMAIN IMPLANTED; THEREFORE, VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS COULD NOT BE PERFORMED DUE TO MISSING LOT NUMBER. DEVICES ARE USED FOR TREATMENT. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. THE REVIEW IDENTIFIED THE EVACUATION OF HEMATOMA APPROXIMATELY SEVEN YEARS AND SIX MONTHS AGO. IMPLANTS REMAIN IMPLANTED. NO OTHER INFORMATION HAS BEEN FOUND. WITH THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: D4 - PRIMARY UNIQUE DEVICE IDENTIFICATION (UDI) NUMBER IS NOT APPLICABLE AS THE LOT NUMBER OF THE DEVICE IS UNKNOWN. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED A HEMATOMA POST IMPLANTATION. A REOPERATION WAS SUBSEQUENTLY PERFORMED TWO DAYS POST IMPLANTATION TO EVACUATE THE HEMATOMA. NO IMPLANTS WERE EXPLANTED. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1581241 TESS HUM CENTRED HEAD 52MM SHOULDER PROSTHESIS PHX BIOMET FRANCE S.A.R.L. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Required Intervention| H SEE H10 NARRATIVE