BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 7538896 · Received May 23, 2018

    Report

    Report Number
    1645337-2018-03182
    Event Type
    Injury
    Date Received
    May 23, 2018
    Date of Event
    May 1, 2018
    Report Date
    May 1, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000532
    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

    THE DEVICE HISTORY RECORD (DHR) OF LOT NUMBERS 5822086 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 CONTAINED GEL WITH A CLEAR APPEARANCE. BROWN FOREIGN MATERIAL WAS OBSERVED WITHIN THE DEVICE. GEL WAS OBSERVED ON THE SHELL SURFACE. THE PRODUCT EVALUATION TEAM¿S VISUAL EXAMINATION OF THE DEVICE REVEALED MISSING MATERIAL MEASURING 6.5 X 3.5 CM ON THE ANTERIOR ASPECT. A CREASE WAS ALSO OBSERVED ON THE ANTERIOR ASPECT. MICROSCOPIC EXAMINATION OF THE RENT EDGES GAVE NO INDICATION AS TO ITS CAUSE. NO OTHER ANOMALIES WERE FOUND. MENTOR PERFORMS 100% INSPECTION AND TESTING OF ALL DEVICES PRIOR TO RELEASE; THE PRODUCT EVALUATION TEAM CONCLUDED THAT THE RENT OCCURRED SOMETIME SUBSEQUENT TO THE REMOVAL OF THE DEVICE FROM ITS PROTECTIVE PACKAGING. THE COMPLAINT WAS CONFIRMED SINCE A RENT WAS FOUND ON THE DEVICE. NO CORRECTIVE ACTION IS REQUIRED SINCE THERE IS NO EVIDENCE THAT THE FAILURES MODES ARE RELATED WITH MANUFACTURING OR PRODUCT DESIGN. 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 MEDICAL PRODUCTS: 550CC MENTOR MEMORYGEL BREAST IMPLANT, CATALOG #3505504BC, LOT #5824264. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) 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 1645337-2018-03183 FOR REPORT ON CONTRALATERAL PROSTHESIS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380795 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 5822086 00081317000532

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention