BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 9137087 · Received September 30, 2019

    Report

    Report Number
    1645337-2019-20188
    Event Type
    Injury
    Date Received
    September 30, 2019
    Date of Event
    February 1, 2018
    Report Date
    April 11, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000136
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT CONTAINS THE SUPPLEMENTAL INFORMATION FOR MENTOR PSR REFERENCE NUMBER (B)(4). THIS DEVICE REPORT IS BEING SUBMITTED LATE AS A RESULT OF THE EXEMPTION TRANSITION PERIOD FOLLOWING THE REVOCATION OF MENTOR¿S PSR EXEMPTION #E2007003. INVESTIGATION SUMMARY: ACCORDING TO THE INFORMATION RECEIVED, A RUPTURE AND CAPSULAR CONTRACTURE ON LEFT-SIDED IMPLANT WERE REPORTED. DURING ANALYSIS OF THE SAMPLE IT WAS OBSERVED TO BE RUPTURED. MICROSCOPIC EXAMINATION WAS PERFORMED. NO EVIDENCE OF INSTRUMENT DAMAGE WAS OBSERVED. NO OTHER ANOMALIES WERE OBSERVED. MICROSCOPIC EXAMINATION OF THE EDGES OF THE RUPTURE DID NOT PROVIDE CONCLUSIVE EVIDENCE OF WHAT COULD BE THE ROOT CAUSE. THE CONDITION OBSERVED ON THE RETURNED SAMPLE MIGHT BE RELATED TO AN EXCESSIVE FORCE APPLIED TO THE DEVICE, THIS CANNOT BE CONCLUSIVELY DETERMINED, AS RUPTURE IS A KNOWN COMPLICATION ASSOCIATED WITH THESE DEVICES AND IS REFERENCED IN THE PRODUCT INSERT DATA SHEET. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 5951739 NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. RUPTURE, AS INDICATED IN THE PRODUCT INSERT DATA SHEET (PIDS), IS A KNOWN COMPLICATION ASSOCIATED WITH MENTOR MAMMARY PROSTHESES. CAUSES OF RUPTURE OF GEL-FILLED IMPLANTS INCLUDE, BUT ARE NOT LIMITED TO THE FOLLOWING EVENTS: DAMAGE FROM SURGICAL INSTRUMENTS, INTRAOPERATIVE OR POSTOPERATIVE TRAUMA,EXCESSIVE STRESSES OR MANIPULATIONS AS MAY OCCUR DURING NORMAL, DAILY ROUTINES INCLUDING CUSTOMARY AND PURPOSEFUL TRAUMA TO THE BREAST. THE REPORTED COMPLAINT WAS CONFIRMED. IT SHOULD BE NOTED THAT AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: RUPTURE, CAPSULAR CONTRACTURE. CONCOMITANT PRODUCTS: 400CC MENTOR MEMORYGEL BREAST IMPLANT ( CATALOG #: 3504001BC, SERIAL #: (B)(4)). MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    THIS REPORT CONTAINS THE SUPPLEMENTAL INFORMATION FOR MENTOR PSR REFERENCE NUMBER (B)(4). IT WAS REPORTED THAT A (B)(6)-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 400CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED POSTOPERATIVE LEFT-SIDED RUPTURE AND CAPSULAR CONTRACTURE. THE DIAGNOSIS WAS CONFIRMED BY A HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH TWO 400CC MENTOR MEMORYGEL BREAST IMPLANTS ( CATALOG #:3504001BC, SERIAL # FOR LEFT: (B)(4), SERIAL # FOR RIGHT: (B)(4)) ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    928315 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 5951739 00081317000136

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention