BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 9708351 · Received February 13, 2020

    Report

    Report Number
    1645337-2020-02099
    Event Type
    Injury
    Date Received
    February 13, 2020
    Date of Event
    January 6, 2020
    Report Date
    January 20, 2020
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317001133
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON MAR 4 2020, THE MENTOR FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. THE DEVICE LOT NUMBER WAS IDENTIFIED AS 5772053. DEVICE EVALUATION SUMMARY: DURING VISUAL INSPECTION OF THE DEVICE, A SHELL WEAR IN THE ANTERIOR VIEW WAS OBSERVED. ADDITIONALLY, A TEAR WITHIN SHELL WEAR WAS OBSERVED IN THE ANTERIOR AND EXTENDING TO THE POSTERIOR VIEW, MEASURING APPROXIMATELY 11.4 CM, CAUSING A RUPTURED. THE EVALUATION DETERMINED THAT THE RUPTURE IS CONSISTENT WITH A SHELL WEAR FOLD RUPTURE. SHELL WEAR FAILURE WHICH IS A KNOWN INHERENT RISK ASSOCIATED WITH THE USE OF GEL-FILLED MAMMARY PROSTHESES AND MAY BE THE RESULT OF ONE OR MORE OF THE FOLLOWING CONTRIBUTING FACTORS: CONTINUOUS AND SUSTAINED STRESSES TO THE DEVICE - SUCH AS TOO SMALL A BREAST POCKET AND FOLDING OR WRINKLING OF THE SHELL IN THE BREAST POCKET. 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. THE SECOND PRODUCT RECEIVED ( LOT NUMBER 5772053) IS A CONCOMITANT (CONTRALATERAL) DEVICE, THEREFORE NO FURTHER ANALYSIS IS REQUIRED. IT SHOULD BE NOTED THAT AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. 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. SINCE NO LOT NUMBER WAS PROVIDED, NO MANUFACTURING RECORD EVALUATION COULD BE PERFORMED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: RUPTURE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT AN UNSPECIFIED BREAST IMPLANTATION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 600CC AND EXPERIENCED RUPTURE ON THE LEFT SIDE POSTOPERATIVELY. THICK, PUS-LIKE FLUID WAS NOTED; HOWEVER, THE PHYSICIAN STATED THERE WAS NO EVIDENCE OF INFECTION. A CULTURE OF THIS FLUID WAS TAKEN. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH MENTOR GEL BREAST IMPLANTS ON (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171694 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 3544600 5772053 00081317001133

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention