BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PROFILE

    MDR report key: 7532123 · Received May 22, 2018

    Report

    Report Number
    1645337-2018-03089
    Event Type
    Injury
    Date Received
    May 22, 2018
    Date of Event
    March 28, 2018
    Report Date
    May 2, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001263
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE MENTOR FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON 7/5/2018. THE ANALYSIS HAS BEGUN, BUT IS NOT COMPLETE AT THIS TIME. WHEN THE INVESTIGATION AND ANALYSIS HAVE BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ALSO ON 7/5/2018, MENTOR RECEIVED ADDITIONAL INFORMATION: EXPLANTATION DATE: (B)(6) 2018. THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT 450CC GEL PROSTHESES ON (B)(6) 2018. CONCOMITANT PRODUCTS: RIGHT MENTOR SMOOTH ROUND MODERATE PROFILE 350CC SALINE PROSTHESIS, CATALOG: 3501655, SERIAL NUMBER: (B)(4), LOT: 5822381. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION SUMMARY: THE DEVICE WAS RECEIVED AT MENTOR WITHOUT FLUID. YELLOW MATERIAL WAS OBSERVED WITHIN THE DEVICE. NO FOREIGN MATERIAL WAS OBSERVED ON THE SHELL SURFACE. DURING VISUAL EXAMINATION OF THE DEVICE, THE PRODUCT EVALUATION TEAM OBSERVED CREASES ON BOTH VIEWS. A RENT WAS DISCOVERED ON THE POSTERIOR VIEW WITHIN ONE OF THE CREASES, MEASURING APPROXIMATELY 0.1 CM. NO OTHER ANOMALIES WERE FOUND. MENTOR PERFORMS 100% INSPECTION AND TESTING OF ALL DEVICES PRIOR TO RELEASE; THE PRODUCT EVALUATION TEAM CONCLUDED THAT THE RENT AND CREASES OCCURRED SOMETIME SUBSEQUENT TO THE REMOVAL OF THE DEVICE FROM ITS PROTECTIVE PACKAGING. THE COMPLAINT OF DEFLATION WAS CONFIRMED SINCE A RENT WAS FOUND ON THE DEVICE. HOWEVER, AT THIS POINT IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF SUCH DAMAGE OR THE ORIGIN OF THE YELLOW MATERIAL OBSERVED. THE DEVICE HISTORY RECORD (DHR) OF LOT NUMBER 5822381 WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. ALL THE IMPLANTS ARE 100% INSPECTED BEFORE LEAVING THE FACILITY. THERE IS NO EVIDENCE THAT THE ISSUE IS RELATED WITH MANUFACTURING. THESE FINDINGS ARE CONSISTENT WITH A CREASE/FOLD FAILURE WHICH IS A KNOWN INHERENT RISK ASSOCIATED WITH THE USE OF SALINE-FILLED MAMMARY PROSTHESES AND MAY BE THE RESULT OF ONE OR MORE OF THE FOLLOWING CONTRIBUTING FACTORS: UNDERINFLATION OR OVERINFLATION OF THE DEVICE, CONTINUOUS AND SUSTAINED STRESSES TO THE DEVICE - SUCH AS CAPSULAR CONTRACTURE OR TOO SMALL A BREAST POCKET, AND FOLDING OR WRINKLING OF THE SHELL IN THE BREAST POCKET. BREAST IMPLANTS ARE NOT CONSIDERED LIFETIME DEVICES AND DEFLATION IS A KNOWN COMPLICATION ASSOCIATED WITH THESE DEVICES AND IS REFERENCED IN OUR PRODUCT INSERT DATA SHEET. WITH THE INFORMATION PROVIDED, THE PRODUCT EVALUATION TEAM CONCLUDED 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).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED ON 1/21/2019 INDICATED THE PATIENT EXPERIENCED BILATERAL CALCIFIED CAPSULES AND RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV. THE EXPLANTATION DATE OF THE DEVICE WAS ON (B)(6) 2019. (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 DEVICE HISTORY RECORD REVIEW IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED ON 5/21/2018, AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A MENTOR SMOOTH ROUND MODERATE PROFILE 350CC SALINE PROSTHESIS. DEFLATION AND CAPSULAR CONTRACTURE BAKER GRADE III ON THE LEFT BREAST PROSTHESIS WAS DIAGNOSED POST PROCEDURE THROUGH A PHYSICAL EXAMINATION. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH AN UNSPECIFIED MENTOR IMPLANT ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376213 MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 5822381 00081317001263

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention