BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PLUS PROFILE

    MDR report key: 12345724 · Received August 19, 2021

    Report

    Report Number
    1645337-2021-09377
    Event Type
    Injury
    Date Received
    August 19, 2021
    Date of Event
    May 11, 2021
    Report Date
    July 29, 2021
    Product Code
    FWM
    UDI-DI
    00081317001454
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 29-OCT-2021, MENTOR RECEIVED ADDITIONAL INFORMATION REGARDING THE PATIENT¿S SYMPTOMS. PREVIOUSLY, IT WAS REPORTED THAT THE PATIENT EXPERIENCED RIGHT-SIDED GRADE III CAPSULAR CONTRACTURE AND DEFLATION. HOWEVER, ADDITIONAL INFORMATION REVEALED THAT THE PATIENT EXPERIENCED ONLY RIGHT-SIDED DEFLATION WITHOUT CAPSULAR CONTRACTURE. THE RELEVANT FIELDS HAVE BEE UPDATED. UPDATED REASON FOR DEVICE EXPLANT AND/OR REOPERATION: DEFLATION. ON 2-NOV-2021, THE INVESTIGATION ON THE SUSPECTED MEDICAL DEVICE WAS UPDATED. ON 3-NOV-2021, IT WAS FOUND THAT B.1. IS PRODUCT PROBLEM WAS NOT CHECKED ON THE PREVIOUS REPORT. INVESTIGATION SUMMARY (UPDATE): THE FOLLOWING STATEMENTS WERE REMOVED ; "MENTOR CONCLUDED THAT THE CAPSULAR CONTRACTURE IN THE PATIENT´S BREAST WAS THE RESULT OF THE BODY´S INDIVIDUAL PHYSIOLOGICAL RESPONSE TO THE IMPLANTATION OF A FOREIGN OBJECT IN SOFT TISSUE. CAPSULAR CONTRACTURE IS A KNOWN COMPLICATION ASSOCIATED WITH THESE DEVICES AND IS REFERENCED IN OUR CURRENT PRODUCT INSERT DATA SHEET." MANUFACTURER'S REFERENCE NUMBER: (B)(4). B.1. IS PRODUCT PROBLEM WAS CHECKED.

    Additional Manufacturer Narrative · 0

    ON 5-OCT-2021, THE SUSPECTED MEDICAL DEVICE WAS RETURNED FOR EVALUATION. ON 11-OCT-2021, MENTOR RECEIVED ADDITIONAL INFORMATION REGARDING THE PATIENT'S SYMPTOMS AND SUSPECTED MEDICAL DEVICE. THE PATIENT EXPERIENCED RIGHT-SIDED DEFLATION. ON 18-OCT-2021, THE INVESTIGATION ON THE SUSPECTED MEDICAL DEVICE WAS COMPLETED. INVESTIGATION SUMMARY: MENTOR CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED DEVICE REVEALED A CREASE/FOLD ON THE ANTERIOR VIEW EXTENDING TO THE POSTERIOR VIEW. ADDITIONALLY, A TEAR WITHIN THE CREASE/FOLD WAS IDENTIFIED ON THE POSTERIOR ASPECT MEASURING APPROXIMATELY 4.5 CM. THE EVALUATION DETERMINED THAT THE CAUSE OF THE RUPTURE IS CONSISTENT WITH NORMAL WEAR. DEFLATION CAN OCCUR AT ANY TIME AFTER IMPLANTATION, BUT IT IS MORE LIKELY TO OCCUR THE LONGER THE IMPLANT IS IMPLANTED. CREATING WRINKLES OR FOLDS SHOULD BE AVOIDED DURING IMPLANTATION OR OTHER PROCEDURES AS IT CAN RESULT IN DEFLATION AT A LATER TIME. BREAST IMPLANTS MAY ALSO SIMPLY WEAR OUT OVER TIME. MENTOR CONCLUDED THAT THE CAPSULAR CONTRACTURE IN THE PATIENT´S BREAST WAS THE RESULT OF THE BODY´S INDIVIDUAL PHYSIOLOGICAL RESPONSE TO THE IMPLANTATION OF A FOREIGN OBJECT IN SOFT TISSUE. CAPSULAR CONTRACTURE IS A KNOWN COMPLICATION ASSOCIATED WITH THESE DEVICES AND IS REFERENCED IN OUR CURRENT PRODUCT INSERT DATA SHEET. AS PART OF MENTOR¿S QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. 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: CAPSULAR CONTRACTURE. DATE OF EXPLANTATION: (B)(6) 2021. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT A REVISION BREAST AUGMENTATION WITH TWO 450CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE PROSTHESES AND EXPERIENCED LEFT-SIDED DEFLATION AND RIGHT-SIDED GRADE III CAPSULAR CONTRACTURE POSTOPERATIVELY. THE DIAGNOSIS WAS CONFIRMED BY A HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO REMOVAL AND REPLACEMENT WITH UNSPECIFIED BREAST IMPLANTS ON (B)(6) 2021. THIS REPORT IS FOR THE RIGHT-SIDED PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1241410 MENTOR SMOOTH ROUND MODERATE PLUS PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM 3502450 5844533 00081317001454

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention