BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 8846491 · Received July 31, 2019

    Report

    Report Number
    1645337-2019-16203
    Event Type
    Injury
    Date Received
    July 31, 2019
    Date of Event
    January 5, 2019
    Report Date
    July 10, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000389
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 08/29/2019, THE MENTOR FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. MENTOR HAS RECEIVED THE FOLLOWING ADDITIONAL INFORMATION ABOUT THE SUSPECT MEDICAL DEVICE: - IT WAS INITIALLY REPORTED THAT THE LOT NUMBER OF THE SUSPECT MEDICAL DEVICE IS 5718787 AND THE SERIAL NUMBER IS (B)(4). NEW INFORMATION STATES THAT THE LOT NUMBER IS 5833147 AND THE SERIAL NUMBER IS (B)(4). - IT WAS INITIALLY REPORTED THAT THE IMPLANTATION DATE IS (B)(6) 2008. NEW INFORMATION STATES THAT THE IMPLANTATION DATE IS (B)(6) 2008. ON 09/05/2019, MENTOR COMPLETED THE INVESTIGATION ON THE SUSPECT MEDICAL DEVICE. DEVICE EVALUATION SUMMARY: ACCORDING TO THE INFORMATION REPORTED, THE PATIENT EXPERIENCED A RUPTURE OF HER BREAST PROSTHESIS. DURING EVALUATION OF THE DEVICE, A RUPTURE WAS OBSERVED BETWEEN SHELL AND PATCH, ALSO SOME CREASES WERE OBSERVED ON ANTERIOR AND ONE OF THEM EXTENDING TO POSTERIOR ASPECT. MICROSCOPIC EXAMINATION OF THE EDGES OF THE TEAR GAVE NO INDICATIONS AS TO CAUSE OF THE FAILURE. NO OTHER ANOMALIES WERE OBSERVED. THE MANUFACTURING RECORDS WERE REVIEWED, AND THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS LOT. 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. RUPTURE IS A KNOWN COMPLICATION ASSOCIATED WITH THESE DEVICES AND IS REFERENCED IN OUR PRODUCT INSERT DATA SHEET. IT SHOULD BE NOTED THAT AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. BASED ON THE INFORMATION REPORTED AND/OR THE PRODUCT INVESTIGATION, THERE IS NO EVIDENCE THAT THE ISSUE IS RELATED WITH THE MANUFACTURING PROCESS. COMPLAINT INFORMATION WILL BE INCLUDED IN COMPLAINT TRENDING THAT IS REVIEWED AND MONITOR BY QUALITY ASSURANCE ON A REGULAR BASIS TO DETERMINE IF FURTHER ACTION IS NECESSARY. 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. A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED, AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE MRE VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: BILATERAL RUPTURE OF BREAST PROSTHESES. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT 800CC GEL BREAST PROSTHESES THAT BOTH RUPTURED AFTER IMPLANTATION. AN ULTRASOUND CONFIRMED BILATERAL RUPTURE. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT 755CC GEL BREAST PROSTHESES ON (B)(6) 2019. THIS MEDWATCH REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639052 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 5833147 00081317000389

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention