BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYSHAPE BREAST IMPLANT

    MDR report key: 20987472 · Received December 20, 2024

    Report

    Report Number
    1645337-2024-14773
    Event Type
    Injury
    Date Received
    December 20, 2024
    Date of Event
    November 1, 2024
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317005360
    PMA / PMN Number
    P060028
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON JANUARY 10, 2025, MENTOR RECEIVED THE FOLLOWING ADDITIONAL INFORMATION: PER A MAGNETIC RESONANCE STUDY, THE LEFT IMPLANT WAS DETERMINED TO BE RUPTURED. HOWEVER, THE OPERATIVE REPORT INDICATED THAT DURING THE REMOVAL SURGERY, BOTH THE LEFT AND RIGHT BREAST IMPLANTS WERE INTACT WHEN REMOVED FROM THE PATIENT. THEREFORE, THE RUPTURED CODE IS NO LONGER APPLICABLE TO THIS FILE. ON JANUARY 20, 2025, MENTOR RECEIVED THE PRODUCT IDENTITY AS THE FOLLOWING: SIZE: 525CC. BRAND NAME: MENTOR MEMORYSHAPE BREAST IMPLANT. CATALOG: 3341405. LOT: 6900121. ON JANUARY 24, 2025, THE MENTOR ANALYSIS LAB RECEIVED THE SUSPECT MEDICAL DEVICE FOR EVALUATION. ON JANUARY 28, 2025, MENTOR COMPLETED AN EVALUATION ON THE RETURNED DEVICE. MENTOR CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED DEVICE REVEALED THAT NO DAMAGE OR ANOMALIES WERE OBSERVED ON THE BREAST IMPLANT. THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING CAUTION: RUPTURE STATUS IDENTIFIED BY MRI EVALUATION INCLUDES BOTH; SUSPECTED RUPTURES, WHICH ARE THOSE RUPTURES IDENTIFIED BY MRI BUT NOT CONFIRMED BY EXPLANTATION AND EXAMINATION OF THE DEVICE, AND CONFIRMED RUPTURES, WHICH ARE THOSE RUPTURES THAT ARE CONFIRMED BY EVALUATION OF THE EXPLANTED DEVICES. 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. D4: UDI: AS THE SERIAL NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. 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. SINCE NO LOT NUMBER WAS PROVIDED, NO MANUFACTURING RECORD EVALUATION COULD BE PERFORMED. D4: UDI: AS ALL OF THE DEVICE CHARACTERISTICS ARE UNKNOWN AT THIS TIME, THE UDI IS CURRENTLY NOT AVAILABLE. 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. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: RUPTURE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF AN UNDISCLOSED MENTOR GEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT REPORTED EXPERIENCING A RUPTURED LEFT BREAST IMPLANT WHICH A MEDICAL PROFESSIONAL CONFIRMED WITH MENTOR. MAGNETIC RESONANCE IMAGING WAS ALSO CONDUCTED. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL WITHOUT REPLACEMENT ON (B)(6) 2024. SEVERAL FOLLOW-UPS HAVE BEEN CONDUCTED, AND NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2203658 MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 6900121 00081317005360

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Required Intervention