BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMOOTH HPG, 400CC

    MDR report key: 14760427 · Received June 21, 2022

    Report

    Report Number
    1645337-2022-07275
    Event Type
    Injury
    Date Received
    June 21, 2022
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000501
    PMA / PMN Number
    P030053
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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. LOT# 5763798: MANUFACTURING DATE: JULY 31, 2007, EXPIRATION DATE: JULY 12, 2012. LOT# 5713617: MANUFACTURING DATE: NOVEMBER 13, 2006, EXPIRATION DATE: NOVEMBER 27, 2011. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: (B)(4). MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON JULY 27, 2022, MENTOR COMPLETED EVALUATION OF THE DEVICE. DEVICE EVALUATION SUMMARY: THE PRODUCT WAS RETURNED TO MENTOR FOR EVALUATION. MENTOR CONDUCTED VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE SMOOTH HPG, 400CC BREAST IMPLANT WAS FOUND TO BE RUPTURED AND RECEIVED IN TWO (2) PARTS, ADDITIONALLY, AN AREA OF SHELL ABRASION WAS OBSERVED ON THE EDGES OF THE RUPTURE. THE EVALUATION DETERMINED THAT THE CAUSE OF THE RUPTURE IS CONSISTENT WITH NORMAL WEAR. SHELL ABRASION SUGGESTS IN-VIVO FOLDING OR CREASING OF THE DEVICE. THIS MAY BE THE RESULT OF THE FOLLOWING FACTORS: CONTINUOUS AND SUSTAINED STRESSES TO THE DEVICE SUCH AS TOO SMALL BREAST POCKET AND FOLDING OR WRINKLING OF THE SHELL IN THE BREAST POCKET. IN SOME CASES, THE BREAST IMPLANTS MAY ALSO WEAR OUT OVER TIME. A SECOND PRODUCT WAS RECEIVED (LOT 5763798). NO ADVERSE EVENTS WERE REPORTED FOR THIS CONCOMITANT (CONTRALATERAL) DEVICE, THEREFORE NO FURTHER ANALYSIS IS REQUIRED. IT SHOULD BE NOTED THAT AS PART OF MENTOR¿S QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST MARKET SURVEILLANCE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON JUNE 29, 2022, MENTOR BECAME AWARE THE PREVIOUSLY UNSPECIFIED IMPACTED SIDE WAS THE LEFT, CONFIRMING THE DEVICE AS SERIAL# (B)(6). ON JULY 5, 2022, THE MENTOR FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETE AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A 400CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED A RUPTURE ON AN UNSPECIFIED SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2022. IT IS UNKNOWN WHICH SIDE WAS IMPACTED, BUT MENTOR WAS PROVIDED WITH THE LOT AND SERIAL NUMBERS (B)(4) FOR THE PATIENT¿S IMPLANTED DEVICES. IF CLARIFICATION IS RECEIVED INDICATING WHICH SIDE WAS IMPACTED, A SUPPLEMENTAL REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1834539 SMOOTH HPG, 400CC PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 3504004BC 5713617 00081317000501

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention