Gluteal Implant, Round, Textured, SDM Size: 14.9cm x 14.9cm x 3.9cmRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M724CCB5T531), received between Apr 12, 2023 and Apr 12, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 12, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  COMPLAINANT REPORTED THAT PATIENT HAD LEFT SIDE GLUTEAL IMPLANT DIAGNOSED WITH RECURRING SEROMAS AND INFECTION. ORGANISM WAS IDENTIFED AS MYCOBACTERIUM AVIUM. PATIENT HAS RECEIVED MULTIPLE COURSES OF ORAL ANTIBIOTICS. (THIS CONSTITUTES THE REPORT FOR THE LEFT SIDE DEVICE. REFER TO 2028924-2023-00003 FOR REPORT ON THE RIGHT SIDE DEVICE INVOLVED IN THE SAME EVENT AND ON THE SAME PATIENT).

  Patient problems: Bacterial Infection; Seroma

  MAUDE report 16725256 ↗
• InjuryApr 12, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  COMPLAINANT REPORTED THAT PATIENT HAD REVISION SURGERY ON RIGHT SIDE GLUTEAL IMPLANT 4 WEEKS POST-OPERATIVELY DUE TO OPENING IN INCISION/POOR WOUND HEALING. THE PATIENT ALSO HAD RECURRING SEROMAS AND WAS TREATED PROPHYLACTICALLY WITH ANTIBIOTICS FOR OVER A YEAR. (THIS CONSTITUTES THE REPORT FOR THE RIGHT SIDE DEVICE. REFER TO 2028924-2023-00004 FOR REPORT ON THE LEFT SIDE DEVICE INVOLVED IN THE SAME EVENT AND ON THE SAME PATIENT.)

  Patient problems: Seroma; Wound Dehiscence

  MAUDE report 16725250 ↗