BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 9569289 · Received January 9, 2020

    Report

    Report Number
    1645337-2020-00554
    Event Type
    Injury
    Date Received
    January 9, 2020
    Report Date
    December 13, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000334
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON 1/15/2020, THE MENTOR FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. THE RIGHT SIDED DEVICE RECEIVED WAS A 450CC MENTOR SMOOTH ROUND HIGH PROFILE MEMORYGEL BREAST IMPLANT CATALOG: 3504504BC, LOT: 6802692, SERIAL NUMBER: (B)(6). CONCOMITANT PRODUCTS: 450CC MENTOR SMOOTH ROUND HIGH PROFILE MEMORYGEL BREAST IMPLANT CATALOG: 3504504BC, LOT: 7482466, SERIAL NUMBER: (B)(6). THE INVESTIGATION OF THE RETURNED DEVICE WAS COMPLETED BY THE FAILURE ANALYSIS LAB ON 1/24/2020. DEVICE EVALUATION SUMMARY: ACCORDING TO THE INFORMATION RECEIVED, IT WAS REPORTED THAT THE PATIENT DEVELOPED CAPSULAR CONTRACTURE. DURING VISUAL INSPECTION OF THE SAMPLE WAS FOUND RUPTURE. IT IS POSSIBLE THE RUPTURE WAS CAUSED BY THE STRESS OCCASIONED TO THE SHELL BY THE CAPSULAR CONTRACTURE. POSTOPERATIVE FORMATION OF A FIBROUS TISSUE CAPSULE AROUND A MAMMARY PROSTHESIS IS A NORMAL PHYSIOLOGIC RESPONSE TO THE IMPLANTATION OF A FOREIGN OBJECT AND OCCURS IN ALL PATIENTS IN VARYING DEGREES. IN SOME CASES, CONTRACTURE OF THE FIBROUS CAPSULE MAY OCCUR. THIS PHENOMENON IS REFERRED TO AS CAPSULAR CONTRACTURE. 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. 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 IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: CAPSULAR CONTRACTURE BAKER GRADE IV NOTE: DATE OF EVENT IS UNKNOWN. CONCOMITANT MEDICAL PRODUCTS: 450CC MENTOR SMOOTH ROUND HIGH PROFILE MEMORYGEL BREAST IMPLANT CATALOG: 3504504BC LOT: 6802692 SERIAL NUMBER: (B)(4). MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST SURGERY WITH A 450CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED RIGHT SIDED CAPSULAR CONTRACTURE BAKER GRADE IV POST PROCEDURE. AS A RESULT, PATIENT HAD AN EXPLANTATION ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30410 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 3504501BC 6802692 00081317000334

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention