BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR PROFILE MODERATE GEL - LUMERA

    MDR report key: 17931926 · Received October 13, 2023

    Report

    Report Number
    1645337-2023-12177
    Event Type
    Injury
    Date Received
    October 13, 2023
    Date of Event
    September 15, 2023
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON OCTOBER 13, 2023, AN INTERNAL SYSTEM UPDATE WAS PERFORMED. CATALOG WAS UPDATED TO 3241357. ON OCTOBER 20, 2023, MENTOR RECEIVED TWO DEVICES FOR EVALUATION. BOTH DEVICES RECEIVED HAD THE SAME LOT NUMBER AND WERE FOUND TO BE RUPTURED. AS SUCH, A NEW FILE WAS GENERATED TO DOCUMENT THE PATIENT'S LEFT DEVICE. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-13055 FOR THE CONTRALATERAL EVENT. AS THE SIDES OF IMPLANTATION COULD NOT BE DIFFERENTIATED, THE DEVICE ASSOCIATED WITH THIS EVALUATION WILL BE REFERRED TO AS DEVICE A. ON OCTOBER 24, 2023, MENTOR COMPLETED A VISUAL INSPECTION OF DEVICE A. DEVICE EVALUATION SUMMARY: VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE BREAST IMPLANT HAD A RUPTURE ALONG THE PATCH. THE EVALUATION DETERMINED THAT THE POSSIBLE CAUSE OF THE RUPTURE IS THE TRAUMA EXPERIENCED. RUPTURE CAN OCCUR AT ANY TIME AFTER IMPLANTATION, BUT IT IS MORE LIKELY TO OCCUR THE LONGER THE IMPLANT IS IMPLANTED. TRAUMA IS A KNOWN INHERENT RISK OF GEL-FILLED MAMMARY PROSTHESIS. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    SINCE THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS CAN BE MADE.  AS SUCH, THE INVESTIGATION WILL BE CLOSED.  IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE, THE INVESTIGATION WILL BE REOPENED AND CONDUCTED AS APPROPRIATE. A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED, AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE MRE VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. MENTOR IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803.  THIS REPORT MAY BE BASED ON INFORMATION WHICH MENTOR HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE.  THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, MENTOR, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MENTOR, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT.  IF CERTAIN INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: RUPTURE MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH A 415CC SILTEX LUMERA GEL BREAST IMPLANT. POST-OPERATIVELY, THE PATIENT EXPERIENCED UNSPECIFIED TRAUMA. THE PATIENT WAS DIAGNOSED WITH A RUPTURE OF HER RIGHT PROSTHESIS, WHICH WAS CONFIRMED VIA COMPUTERIZED TOMOGRAPHY SCAN. AS A RESULT, THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1749350 CONTOUR PROFILE MODERATE GEL - LUMERA PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 5612362

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention