BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 7538895 · Received May 23, 2018

    Report

    Report Number
    1645337-2018-03183
    Event Type
    Injury
    Date Received
    May 23, 2018
    Date of Event
    March 29, 2018
    Report Date
    May 1, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000549
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD (DHR) OF LOT NUMBERS 5824264 WAS REVIEWED ON 6/1/2018 AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICES WERE MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. THE INVESTIGATION OF THE RETURNED PRODUCT WAS COMPLETED BY THE FAILURE ANALYSIS LAB ON 6/18/2018. DEVICE EVALUATION SUMMARY: IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE UNDERWENT BREAST AUGMENTATION REVISION WITH A 500CC MENTOR MEMORYGEL BREAST IMPLANT (RIGHT), AND A 550CC MENTOR MEMORYGEL BREAST IMPLANT (LEFT). UPON RECEIPT BY MENTOR. THE DEVICE WAS RECEIVED WITH CLEAR GEL. BROWN FOREIGN MATERIAL WAS OBSERVED WITHIN THE DEVICE, AND NO MATERIAL ON SHELL SURFACE. THE DEVICE APPEARS WITH A CREASE AND BUBBLES ON THE ANTERIOR ASPECT. NO ANOMALIES WERE OBSERVED. THE PRODUCT EVALUATION TEAM CONCLUDED THE CREASES OCCURRED SOMETIME AFTER THE REMOVAL OF THE DEVICE FROM ITS PROTECTIVE PACKAGING. A ROOT CAUSE FAILURE ANALYSIS WILL NOT BE CONDUCTED SINCE THE INVESTIGATION COULD NOT CONFIRM THAT AN ACTUAL FAILURE OF THE DEVICE TO CONFORM TO EXPECTED PERFORMANCE HAD OCCURRED. BECAUSE THE PRODUCT EVALUATION TEAM WAS UNABLE TO CONFIRM ANY UNUSUAL FAILURE MODE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. CAPSULAR CONTRACTURE IS A KNOWN COMPLICATION ASSOCIATED WITH THESE DEVICES AND IS REFERENCED IN OUR CURRENT 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: 550CC MENTOR MEMORYGEL BREAST IMPLANT, CATALOG #3505004BC, LOT #5822086. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) -YEAR-OLD CAUCASIAN FEMALE UNDERWENT BREAST AUGMENTATION REVISION WITH A 500CC MENTOR MEMORYGEL BREAST IMPLANT (RIGHT), AND A 550CC MENTOR MEMORYGEL BREAST IMPLANT (LEFT). ON (B)(6) 2018 THE PATIENT WAS DIAGNOSED WITH LEFT SIDED BAKER¿S GRADE III CAPSULAR CONTRACTURE. ON (B)(6) 2018, DURING REPLACEMENT SURGERY, RIGHT SIDED RUPTURE WAS DISCOVERED. BILATERAL PROSTHESIS REPLACEMENT WITH 350CC MENTOR MEMORYGEL BREAST IMPLANTS WERE PERFORMED, AND THE PATIENT¿S LAST KNOWN CONDITION WAS FULLY RECOVERED. (SEE 1645337-2018-03182 FOR REPORT ON CONTRALATERAL PROSTHESIS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380794 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 5824264 00081317000549

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention