BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 8318894 · Received February 7, 2019

    Report

    Report Number
    1645337-2019-08402
    Event Type
    Injury
    Date Received
    February 7, 2019
    Date of Event
    December 17, 2018
    Report Date
    January 15, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000709
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED FOR THE FINISHED DEVICE NUMBER 202491 ON 3/9/2019, AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. THE INVESTIGATION OF THE RETURNED PRODUCT WAS COMPLETED BY THE FAILURE ANALYSIS LAB ON 3/11/2019. DEVICE EVALUATION SUMMARY: IT WAS REPORTED THAT A 75-YEAR-OLD CAUCASIAN FEMALE UNDERWENT BREAST RECONSTRUCTION REVISION WITH A 375CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED RIGHT SIDED RUPTURE POST PROCEDURE. THE PATIENT HAD TRIPPED AND EXPERIENCED TRAUMA TO THE BREAST, AND RUPTURE WAS DIAGNOSED THROUGH ULTRASOUND. UPON RECEIPT BY MENTOR THE GEL CONTAINED IN THE DEVICE APPEARS CLEAR. NO FOREIGN MATERIAL WAS OBSERVED WITHIN THE DEVICE OR ON THE SHELL SURFACE. THE MENTOR PRODUCT ANALYSIS LAB DISCOVERED PARALLEL LINES OF SHELL WEAR WERE ALSO OBSERVED ON THE ANTERIOR ASPECT, SUGGESTING IN-VIVO FOLDING OR CREASING OF THE DEVICE. LEAK TESTING WAS PERFORMED IN ACCORDANCE WITH MENTOR PROCEDURES AND NO LEAK SITES WERE DETECTED. NO OTHER ANOMALIES WERE DISCOVERED. THE COMPLAINT WAS NOT CONFIRMED. THERE IS NO EVIDENCE THAT THE ISSUE IS RELATED WITH MANUFACTURING. BECAUSE MENTOR PRODUCT ANALYSIS LAB WAS UNABLE TO CONFIRM ANY UNUSUAL FAILURE MODE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. RUPTURE IS A KNOWN COMPLICATION ASSOCIATED WITH THESE DEVICES AND IS REFERENCED IN OUR PRODUCT INSERT DATA SHEET. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    THE MENTOR FAILURE ANALYSIS LAB HAS RECEIVED THE DEVICE FOR EVALUATION. THE ANALYSIS HAS BEGUN, BUT IS NOT COMPLETE AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. A DEVICE HISTORY RECORD REVIEW IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS: 325CC MENTOR MEMORYGEL BREAST IMPLANT, CATALOG #3507325BC, SERIAL (B)(4). MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE UNDERWENT BREAST RECONSTRUCTION REVISION WITH A 375CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED RIGHT SIDED RUPTURE POST PROCEDURE. THE PATIENT HAD TRIPPED AND EXPERIENCED TRAUMA TO THE BREAST, AND RUPTURE WAS DIAGNOSED THROUGH ULTRASOUND. AS A RESULT, THE DEVICE WAS EXPLANTED ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107717 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 202491 00081317000709

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention