ContourFlex™ Gluteal Implant, Round (Natural Contour) Size 3Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M724CCB5NC31), received between Dec 31, 2018 and Dec 31, 2018 — classified as 2 injuries.

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.

• InjuryDec 31, 2018Adverse Event Without Identified Device or Use Problem

  COMPLAINANT REPORTED THAT PATIENT COMPLAINED OF MAJOR PAIN, POSSIBLY DUE TO SHIFTING OF THE IMPLANTS. DEVICES WERE EXPLANTED AND REPLACED BILATERALLY APPROXIMATELY 8 MONTHS POST-OPERATIVELY. (THIS REPORT IS FOR THE LEFT SIDE DEVICE. REFER TO 2028924-2018-00010 FOR REPORT ON THE RIGHT SIDE DEVICE INVOLVING THE SAME PATIENT AND SAME EVENT.)

  Patient problems: Pain

  MAUDE report 8206655 ↗
• InjuryDec 31, 2018Adverse Event Without Identified Device or Use Problem

  COMPLAINANT REPORTED THAT PATIENT COMPLAINED OF MAJOR PAIN, POSSIBLY DUE TO SHIFTING OF THE IMPLANTS. DEVICES WERE EXPLANTED AND REPLACED BILATERALLY APPROXIMATELY 8 MONTHS POST-OPERATIVELY. (THIS REPORT IS FOR THE RIGHT SIDE DEVICE. REFER TO 2028924-2018-00011 FOR REPORT ON THE LEFT SIDE DEVICE INVOLVING THE SAME PATIENT AND SAME EVENT.)

  Patient problems: Pain

  MAUDE report 8206645 ↗