BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AART CUSTOM GLUTEAL IMPLANT

    MDR report key: 19762795 · Received July 17, 2024

    Report

    Report Number
    3003897287-2022-71420
    Event Type
    Injury
    Date Received
    July 17, 2024
    Date of Event
    August 17, 2020
    Report Date
    June 1, 2026
    Manufacturer
    DSAART, LLC
    Product Code
    MIB
    PMA / PMN Number
    K021839
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT HAD GLUTEAL AUGMENTATION IN (B)(6) 2016, RETURNED TO DOCTOR SOMETIME IN 2020 (REASON UNKNOWN) TO WHICH AN MRI REVEALED A POSSIBLE ISSUE WITH LEFT SIDE IMPLANTS. THE DECISION WAS MADE TO REPLACE THE IMPLANT AND IN (B)(6) 2020 THE REPLACEMENT PROCEDURE WAS PERFORMED. DURING THE REMOVAL THE LEFT IMPLANT IT WAS FOUND TO HAVE FRACTURED IN MULTIPLE PIECES. THE IMPLANT WAS REMOVED IN ITS ENTIRETY AND REPLACED WITH NEW IMPLANT. THE DOCTOR DID NOT SAVE THE REMOVED IMPLANT BUT HAD TAKEN PICTURES THAT WE WERE UNABLE TO OBTAIN AS THE OFFICE COULD NOT FIND THEM. PER THE DOCTORS PROGRESS NOTES (DATED (B)(6) 2020) THE PATIENT HAS DONE WELL FOLLOWING THE REPLACEMENT AND WILL CONTINUE FOLLOW UP CARE AS DIRECTED. UNABLE TO DO ANY TESTING OR EXAMINATION OF EXPLANTED IMPLANT AS THE DOCTOR DISCARDED IMMEDIATELY AFTER THE SURGERY.

    Description of Event or Problem · 0

    PATIENT HAD GLUTEAL AUGMENTATION IN (B)(6) 2016, RETURNED TO DOCTOR SOMETIME IN 2020 (REASON UNKNOWN) TO WHICH AN MRI REVEALED A POSSIBLE ISSUE WITH LEFT SIDE IMPLANTS (SEE DOCTORS NOTES FOR DETAILS) THE DECISION WAS MADE TO REPLACE THE IMPLANT AND IN (B)(6) 2020 THE REPLACEMENT PROCEDURE WAS PERFORMED. DURING THE REMOVAL THE LEFT IMPLANT IT WAS FOUND TO HAVE FRACTURED IN MULTIPLE PIECES. THE IMPLANT WAS REMOVED IN ITS ENTIRETY AND REPLACED WITH NEW IMPLANT. THE DOCTOR DID NOT SAVE THE REMOVED IMPLANT BUT HAD TAKEN PICTURES THAT WE WERE UNABLE TO OBTAIN AS THE OFFICE COULD NOT FIND THEM. PER THE DOCTORS PROGRESS NOTES (DATED (B)(6) 2020) THE PATIENT HAS DONE WELL FOLLOWING THE REPLACEMENT AND WILL CONTINUE FOLLOW UP CARE AS DIRECTED. UNABLE TO DO ANY TESTING OR EXAMINATION OF EXPLANTED IMPLANT AS THE DOCTOR DISCARDED IMMEDIATELY AFTER THE SURGERY. DR EXPLANTED AND REPLACED IMPLANT IN QUESTION. FOLLOWED UP WITH PATIENT ON (B)(6) 2020, PATIENT RECOVERING WELL. FOLLOW UP (B)(6) 2020, PATIENT CONTINUES TO DO WELL PER DR. ORIGINAL IMPLANTS PURCHASED (B)(6) 2016 (LOT # 16-04-003). REPLACEMENT IMPLANT PURCHASED (B)(6) 2020 (LOT # 20-07-041).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2046994 AART CUSTOM GLUTEAL IMPLANT GLUTEAL IMPLANT MIB DSAART, LLC 16-04-003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention