BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 16742978 · Received April 14, 2023

    Report

    Report Number
    1645337-2023-04394
    Event Type
    Injury
    Date Received
    April 14, 2023
    Date of Event
    January 19, 2023
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION COMPLETED ON JUNE 05 , 2023: THE PRODUCT WAS RETURNED TO MENTOR FOR EVALUATION. MENTOR CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE CONTOUR PROFILE HIGH GEL - LUMERA 440CC BREAST IMPLANT WAS FOUND TO BE RUPTURED AND RECEIVED IN TWO PARTS. IN ADDITION, AN AREA OF SILTEX CRACKING WAS OBSERVED ON THE EDGES OF THE TEAR. THE EVALUATION DETERMINED THAT THE CAUSE OF THE RUPTURE IS CONSISTENT WITH NORMAL WEAR. SILTEX CRACKING IS DEFINED AS A MATERIAL SEPARATION OCCURRING IN THE SILTEX LAYER AND CAN EVENTUALLY PROGRESS THROUGH THE SHELL OF SILTEX DEVICES. SILTEX CRACKING IS ULTIMATELY A RESULT OF HIGH STRESSES. AS PART OF MENTOR¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. CAPA ACTIVITY WAS NOT REQUIRED. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REFERENCE NUMBER: THE MANUFACTURING RECORD EVALUATION (MRE) WAS REVIEWED, AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE MRE REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING RECORD EVALUATION (MRE) WAS REVIEWED, AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE MRE REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    UPDATED INFORMATION REGARDING SUSPECT DEVICE INFORMATION WHICH RECEIVED ON MAY 9, 2023. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED ON APRIL 14, 2023 INDICATED THE FOLLOWING: AS FOLLOW: SUSPECT DEVICES INFORMATION: LEFT 324-1151 SN (B)(6) DATE OF IMPLANTATION: (B)(6) 2006 RIGHT 324-1301 SN (B)(6) DATE OF IMPLANTATION: (B)(6) 2006 THE PATIENT ALSO UNDERWENT TOTAL CAPSULECTOMY. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    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: SILENT RUPTURE. MENTOR IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH MENTOR HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, MENTOR, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MENTOR, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF CERTAIN INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 72-YEAR-OLD HISPANIC FEMALE WHO UNDERWENT A BREAST RECONSTRUCTION REVISION WITH AN UNKNOWN MENTOR SILICONE, BREAST IMPLANT, EXPERIENCED BILATERAL SILENT RUPTURE POSTOPERATIVELY. THE ISSUE WAS DIAGNOSED THROUGH ULTRASOUND EXAMINATION. AS A RESULT, PATIENT UNDERWENT BILATERAL TOTAL CAPSULECTOMY, AND BILATERAL REPLACEMENTS AS FOLLOW: LEFT REF # SDC-130H, SERIAL NUMBER (B)(4) RIGHT CAT: SDC-130H, SERIAL NUMBER (B)(4) ON (B)(6) 2023. THIS REPORT RELATES TO THE LEFT PROSTHESIS. NOTE: THE SYSTEM CREATS AN ERROR IN TAKING THE DEVICE CATALOG NUMBER, CORRECTION IS IN PROGRESS, SUPPLEMENTAL WILL BE SEND ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392293 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 5700321

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Required Intervention