ContourFlex™ Gluteal Implant, Anatomical (Teardrop) Size 1Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M724CCB611), received between Feb 8, 2017 and Feb 8, 2017 — 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 18, 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.

• InjuryFeb 8, 2017Patient-Device Incompatibility

  COMPLAINANT REPORTED THAT PATIENT WHO HAD IMPLANTECH GLUTEAL IMPLANTS PLACED IN THE CALF REGION BILATERALLY, SUBSEQUENTLY DEVELOPED SEROUS FLUID ACCUMULATION IN THE AREA OF THE RIGHT SIDE IMPLANT. PATIENT HAD THE AREA DRAINED REPEATEDLY STARTING APPROXIMATELY 2 MONTHS POST-OPERATIVELY. FOR THE NEXT 21 MONTHS, THE PATIENT HAD THE AREA DRAINED REPEATEDLY AND TOOK SEVERAL COURSES OF ORAL ANTIBIOTICS, AS WELL. THE PATIENT HAD THE RIGHT SIDE DEVICE EXPLANTED APPROXIMATELY 23 MONTHS POST-OPERATIVELY. COMPLAINANT REPORTED THAT CULTURES TAKEN 3 WEEKS BEFORE EXPLANT AND ON THE DAY OF THE EXPLANT CAME BACK NEGATIVE. THERE WAS A CULTURE TAKEN FROM THE PATIENT ABOUT 8 DAYS AFTER THE EXPLANT SURGERY, AND PSUEDOMONAS AERUGINOSA WAS IDENTIFIED. IN LATEST FOLLOW UP WITH COMPLAINANT, PATIENT'S INFECTION APPEARS TO BE RESOLVED, HOWEVER PATIENT HAS NOT SCHEDULED ANY REPLACEMENT.

  Patient problems: Failure of Implant; Fluid Discharge; Post Operative Wound Infection

  MAUDE report 6311439 ↗