BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TESS HUM ANATOMICAL COROLLA S2

    MDR report key: 18324070 · Received December 14, 2023

    Report

    Report Number
    3006946279-2023-00117
    Event Type
    Injury
    Date Received
    December 14, 2023
    Date of Event
    February 18, 2016
    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
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10 ¿ MEDICAL DEVICES: TESS HUM STEM SMALL; ITEM# P1700128; LOT# UNKNOWN; TESS GLENOID CEMENTED PE S3; ITEM# P1700426; LOT# UNKNOWN; TESS HUM CENTRED HEAD 52MM; ITEM# P1700140; LOT# UNKNOWN. G2 ¿ FOREIGN: FRANCE. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3006946279 - 2023 - 00115; 3006946279 - 2023 - 00116 ; 3006946279 - 2023 - 00117 ; 3006946279 - 2023 - 00118. 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 AND RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. THE REVIEW IDENTIFIED THAT THE OSTEOLYSIS STARTED TO APPEARED 1 YEAR POST-OP. SINCE THAT, IT HAS EXTENDED AND THERE IS NOW ALSO RADIOLUCENCY OF BOTH GLENOID AND HUMERUS IN ADDITION TO THE OSTEOLYSIS. NO CONTRIBUTING FACTOR OF THE EVENT HAS BEEN FOUND IN THE MEDICAL RECORDS. 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 UNDERWENT AN INITIAL RIGHT ANATOMIC TOTAL SHOULDER SURGERY AND APPROXIMATELY 1 YEAR LATER AT THE PATIENT 1-YEAR POST-OP APPOINTMENT RADIOLUCENCY AND OSTEOLYSIS WAS NOTED ON X-RAY. THE PATIENT HAS MILD PAIN AND CAN COMPLETE 81-100% OF ADL¿S. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    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
    1979530 TESS HUM ANATOMICAL COROLLA S2 PROSTHESIS, INTERNAL, JOINT, SHOULDER, TOTAL PHX BIOMET FRANCE S.A.R.L. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Other SEE H10 NARRATIVE.