ContourFlex™ Gluteal Implant, Round Size 4Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M724CCB541), received between Mar 21, 2018 and Mar 21, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 21, 2018Patient-Device Incompatibility

  COMPLAINANT REPORTED THAT PATIENT HAD GLUTEAL IMPLANTS EXPLANTED BILATERALLY APPROXIMATELY 17 DAYS POST-OPERATIVELY DUE TO INFECTION. THE PATIENT PRESENTED WITH PAIN, REDNESS, SWELLING AND SLIGHT NECROSIS ON THE RIGHT SIDE 10 DAYS POST-OPERATIVELY AND WAS PRESCRIBED A 10 DAY COURSE OF CLINDAMYCIN PO. WHEN ISSUES DID NOT APPEAR TO BE RESOLVING AS FULLY AS DESIRED, THE DECISION WAS MADE TO EXPLANT THE DEVICS. A CULTURE WAS TAKEN, AND RESULTS FOUND CITROBACTER BRAAKII. PATIENT HAS SIGNIFICANT MEDICAL HISTORY OF BEING PRE-DIABETIC AND BEING (B)(6) SINCE 2002. PHYSICIAN'S OFFICE CITED POOR PATIENT AFTER CARE AS ONE REASON FOR THE EVENT, AND INITIALLY DID NOT FEEL DEVICES CAUSED OR CONTRIBUTED TO THE EVENT. SUBSEQUENT F/U WITH COMPLAINANT INDICATED THAT DEVICE INVOLVEMENT COULD NOT BE RULED OUT, HENCE IMPLANTECH HAS ELECTED TO REPORT THIS EVENT.

  Patient problems: Bacterial Infection

  MAUDE report 7360090 ↗