BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 7483808 · Received May 3, 2018

    Report

    Report Number
    1645337-2018-02630
    Event Type
    Injury
    Date Received
    May 3, 2018
    Date of Event
    February 21, 2018
    Report Date
    April 13, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2018, IT WAS REPORTED TO MENTOR THAT 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. ON (B)(6) 2018, IT WAS REPORTED TO MENTOR THAT THE REPLACEMENT DEVICES WERE GEL MENTOR MEMORYGEL BREAST IMPLANT 350CC. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    ON 06/07/18, IT WAS REPORTED TO MENTOR THAT THE DATE OF EXPLANTATION IS (B)(6) 2018. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    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. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. CONCOMITANT MEDICAL PRODUCTS: WITH GEL MENTOR MEMORYGEL BREAST IMPLANTS 350CC, CATALOG NUMBER 3543507, LOT NUMBER 211051. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2018, IT WAS REPORTED TO MENTOR THAT THE DEVICE EVALUATION AND INVESTIGATION HAVE BEEN COMPLETED. UPON RECEIPT BY MENTOR, THE DEVICE CONTAINED GEL WITH CLEAR APPEARANCE. NO FOREIGN MATERIAL WAS OBSERVED WITHIN THE DEVICE. BLACK MATERIAL WAS OBSERVED ON THE SHELL SURFACE. PE¿S VISUAL EXAMINATION OF THE DEVICE REVEALED PARALLEL LINES OF SHELL WEAR ON THE ANTERIOR VIEW EXTENDING TO THE POSTERIOR, SUGGESTING IN-VIVO FOLDING OR CREASING OF THE DEVICE. A RENT MEASURING 2.5 CM WAS OBSERVED ON THE POSTERIOR VIEW, BETWEEN THE SHELL WEAR. NO OTHER ANOMALIES WERE FOUND. MENTOR PERFORMS 100% INSPECTION AND TESTING OF ALL DEVICES PRIOR TO RELEASE; PE CONCLUDED THAT THE RENT AND SHELL WEAR OCCURRED SOMETIME SUBSEQUENT TO THE REMOVAL OF THE DEVICE FROM ITS PROTECTIVE PACKAGING. THE COMPLAINT OF RUPTURE WAS CONFIRMED SINCE A RENT WAS FOUND ON THE DEVICE. HOWEVER, AT THIS POINT IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF SUCH DAMAGE OR THE ORIGIN OF THE BLACK MATERIAL OBSERVED. BECAUSE MENTOR PERFORMS 100% INSPECTION AND TESTING OF ALL DEVICES PRIOR TO RELEASE, PE CONCLUDED THAT THE RENT AND SHELL WEAR OCCURRED SOMETIME SUBSEQUENT TO THE REMOVAL OF THE DEVICE FROM ITS PROTECTIVE PACKAGING. THE SEVERITY LEVEL FOR THIS COMPLAINT CODE WAS DETERMINED TO BE A S3, WHICH IS DEFINED AS: NECESSITATES INTRUSIVE MEDICAL OR SURGICAL INTERVENTION. CORRECTIVE ACTION: NO CORRECTIVE ACTION IS REQUIRED SINCE THERE IS NO EVIDENCE THAT THE FAILURES MODES ARE RELATED WITH MANUFACTURING OR PRODUCT DESIGN. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION WITH GEL MENTOR MEMORYGEL BREAST IMPLANTS 350CC AND EXPERIENCED BILATERAL RUPTURE. THE RUPTURE WAS OBSERVED BY THE PATIENT ON (B)(6) 2018 AND CONFIRMED BY THE HEALTHCARE PROFESSIONAL BY ULTRASOUND ON (B)(6) 2018. AS A RESULT, THE PATIENT HAD UNDERGONE EXPLANTATION ON (B)(6) 2018. THIS MEDWATCH IS FOR THE RIGHT BREAST IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325694 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 211051

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention