ContourFlex™ Gluteal Implant, Anatomical (Teardrop) Size 3Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI M724CCB631), received between May 23, 2018 and Dec 1, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 1, 2022Insufficient Device Problem Information

  COMPLAINANT REPORTED THAT PATIENT HAD GLUTEAL IMPLANTS EXPLANTED APPROXIMATELY 3.5 MONTHS POST-OPERATIVELY DUE TO RECURRING SEROMAS. (THIS CONSTITUTES THE REPORT FOR THE RIGHT SIDE DEVICE. REFER TO 2028924-2022-00013 FOR REPORT ON THE LEFT SIDE DEVICE INVOLVED IN THE SAME EVENT AND ON THE SAME PATIENT.)

  Patient problems: Insufficient Information

  MAUDE report 15898012 ↗
• InjuryDec 1, 2022Patient-Device Incompatibility

  COMPLAINANT REPORTED THAT PATIENT HAD GLUTEAL IMPLANTS EXPLANTED APPROXIMATELY 3.5 MONTHS POST-OPERATIVELY DUE TO RECURRING SEROMAS. (THIS CONSTITUTES THE REPORT FOR THE LEFT SIDE DEVICE. REFER TO 2028924-2022-00012 FOR REPORT ON THE RIGHT SIDE DEVICE INVOLVED IN THE SAME EVENT AND ON THE SAME PATIENT.)

  Patient problems: Seroma

  MAUDE report 15896194 ↗
• InjuryMay 23, 2018Adverse Event Without Identified Device or Use Problem

  COMPLAINANT REPORTED THAT PATIENT WHO RECEIVED GLUTEAL IMPLANTS HAD TO HAVE DEVICES EXPLANTED BILATERALLY NINE DAYS POST-OPERATIVELY DUE TO SIGNS OF INFECTION AND APPARENT ORGAN FAILURE. PATIENT STARTED TO EXPERIENCE PROBLEM FAIRLY SOON AFTER IMPLANTATION. WHEN SEEN 1 WEEK POST-OP, PATIENT HAD SECRETIONS, PUS AND FOUL ODOR WHICH LED REPORTING PHYSICIAN TO THINK THERE WAS AN INFECTION. CULTURE WAS TAKEN WHICH ENDED UP HAVING A NEGATIVE RESULT. PATIENT CONTINUED TO GET WORSE AND APPEAR TO DEVELOP ORGAN FAILURE (KIDNEY, ETC.) ANOTHER CULTURE WAS TAKEN AND AGAIN THE RESULTS WERE NEGATIVE. REPORTING PHYSICIAN CONSIDERED THE POSSIBILITY OF SEPSIS, BUT THE RESULTS OF ALL THE CULTURES TAKEN FAILED TO SUPPORT PRESENCE OF ANY BACTERIAL INFECTION. AFTER REMOVAL, THE PATIENT'S SYMPTOMS HAVE RESOLVED.

  Patient problems: Multiple Organ Dysfunction Syndrome; Patient Problem/Medical Problem

  MAUDE report 7538909 ↗