Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSD-360Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07445161010599), received between Nov 14, 2024 and Apr 22, 2026 — classified as 6 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryApr 22, 2026Device Appears to Trigger Rejection

  USA. ALLEGEDLY, A PATIENT WHO UNDERWENT A BREAST SURGERY AUGMENTATION ON (B)(6) 2025, DEVELOPED A CAPSULAR CONTRACTURE BAKER GRADE III/IV ON HER LEFT BREAST. SHE HASN'T UNDERGONE ANY ADDITIONAL SURGERY. THE INVESTIGATION HAS BEEN COMPLETED.

  Patient problems: Capsular Contracture

  MAUDE report 24958769 ↗
• InjuryJun 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ARGENTINA. IT WAS REPORTED THAT A PATIENT WHO UNDERWENT IMPLANTATION SURGERY IN (B)(6) 2025, REQUIRED AN EXPLANTATION TEN DAYS AFTER DUE TO A SKIN INFECTION. EFFORTS TO GATHER ADDITIONAL INFORMATION ARE ONGOING, AND THE INVESTIGATION REMAINS IN PROGRESS.

  Patient problems: Unspecified Infection

  MAUDE report 22162869 ↗
• InjuryMay 23, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  KOREA- IT WAS REPORTED THAT A PATIENT COMPLAINT ABOUT A FIRMNESS AND ASYMMETRY IN HER RIGHT BREAST. SHE WAS DIAGNOSED WITH A CAPSULAR CONTRACTURE BAKER GRADE IV UNILATERAL RIGHT BREAST ((B)(6)).

  Patient problems: Capsular Contracture

  MAUDE report 22079960 ↗
• InjuryDec 2, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IT WAS REPORTED A LEFT IMPLANT CHANGE DUE TO CAPSULAR FIBROSIS. NO PATIENT DEMOGRAPHICS, SUCH AS AGE, WEIGHT, OR ETHNICITY, WERE PROVIDED BY THE REPORTER, AND NO ADVERSE OUTCOMES FOR THE PATIENT HAVE BEEN NOTED. EFFORTS TO GATHER ADDITIONAL INFORMATION ARE ONGOING, AND THE INVESTIGATION REMAINS IN PROGRESS.

  Patient problems: Capsular Contracture

  MAUDE report 20825536 ↗
• InjuryNov 14, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT COMPLAINED ABOUT FIRMNESS AT HER BREASTS. CAPSULAR CONTRACTURE BAKER GRADE IV WAS DIAGNOSED. NO PATIENT DEMOGRAPHICS, SUCH AS AGE, WEIGHT, OR ETHNICITY, WERE PROVIDED BY THE REPORTER, AND NO ADVERSE OUTCOMES FOR THE PATIENT HAVE BEEN NOTED. EFFORTS TO GATHER ADDITIONAL INFORMATION ARE ONGOING, AND THE INVESTIGATION REMAINS IN PROGRESS.

  Patient problems: Capsular Contracture

  MAUDE report 20685336 ↗
• InjuryNov 14, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT COMPLAINED ABOUT FIRMNESS AT HER BREASTS. CAPSULAR CONTRACTURE BAKER GRADE IV WAS DIAGNOSED. NO PATIENT DEMOGRAPHICS, SUCH AS AGE, WEIGHT, OR ETHNICITY, WERE PROVIDED BY THE REPORTER, AND NO ADVERSE OUTCOMES FOR THE PATIENT HAVE BEEN NOTED. EFFORTS TO GATHER ADDITIONAL INFORMATION ARE ONGOING, AND THE INVESTIGATION REMAINS IN PROGRESS.

  Patient problems: Capsular Contracture

  MAUDE report 20685091 ↗