BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TESS HUM CENTERED HEAD 43

    MDR report key: 18353804 · Received December 19, 2023

    Report

    Report Number
    3006946279-2023-00121
    Event Type
    Injury
    Date Received
    December 19, 2023
    Date of Event
    April 23, 2019
    Report Date
    February 17, 2025
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    PHX
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; 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 AVASCULAR NECROSIS AS CONTRIBUTING FACTOR OF THE EVENT. MOREOVER, PATIENT FALL ON SHOULDER (B)(6) 2019, WHICH LED TO THE PROSTHESIS REPLACEMENT FOR MECHANICAL REASONS. THE ROOT CAUSE OF THE REPORTED ISSUE IS ATTRIBUTED TO A PATIENT ACCIDENT (FALL ON HIS SHOULDER). AS PER INSTRUCTIONS FOR USE, FALLS ARE LISTED AS FACTORS WHICH MAY COMPROMISE SUCCESSFUL IMPLANTATION AND DEVICE PERFORMANCE. 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. H3 OTHER TEXT : DEVICE LOCATION IS UNKNOWN.

    Additional Manufacturer Narrative · 0

    (B)(4). G2-FOREIGN- FRANCE. D10. ITEM#:P1700484 ;LOT#:UNKNOWN ;ITEM NAME: TESS GLEN INSERT S1 ; ITEM#:P1700440 ;LOT#:UNKNOWN ;ITEM NAME: HUM ANATOMICAL COROLLA S0 ; ITEM#:P1700331 ;LOT#:UNKNOWN ;ITEM NAME: TESS GLENOID CMTLESS BSEPLT S1; ITEM#:P1700128 ;LOT#:UNKNOWN ;ITEM NAME: TESS HUM STEM SMALL ; MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3006946279 - 2023 - 00122, 3006946279 - 2023 - 00095. INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    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

    INITIAL RIGHT ANATOMIC SHOULDER ARTHROPLASTY PERFORMED. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO CUFF LESION FOUR (4) YEARS SIX (6) MONTHS AFTER INITIAL SURGERY. NO FURTHER DETAILS OR OUTCOMES HAVE BEEN PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO CUFF LESION. DUE DILIGENCE PERFORMED, ALL THE RECEIVED INFORMATION WAS CAPTURED.

    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
    1350377 TESS HUM CENTERED HEAD 43 PROSTHESIS, SHOULDER PHX BIOMET FRANCE S.A.R.L. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Required Intervention| H