ContourFlex™ Gluteal Implant, Round Size 2Recalls & reported problems
Implantech Associates, Inc. · Contoured Carving Block Implant · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M724CCB521), received between Nov 27, 2018 and Nov 27, 2018 — classified as 1 injury.
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
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Code Available1
- Swelling1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 27, 2018Adverse Event Without Identified Device or Use Problem
COMPLAINANT REPORTED THAT PATIENT EXPERIENCED SEROUS FLUID ACCUMULATION ON THE RIGHT SIDE AFTER BILATERAL PLACEMENT WITH GLUTEAL IMPLANTS. THE PHYSICIAN MADE MULTIPLE ATTEMPTS TO DRAIN THE RIGHT SIDE, HOWEVER SWELLING AND SEROUS FLUID ACCUMULATION PERSISTED. APPROXIMATELY 9 MONTHS POST-OPERATIVELY, THE RIGHT SIDE DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: No Code Available; Swelling
MAUDE report 8106766 ↗
Other Elastomer, Silicone Block devices
- Himplant Pre-Formed Penile Silicone Block Extra Large - SoftInternational Medical Devices, Inc. · Elastomer, Silicone Block10 reports
- Himplant Pre-Formed Penile Silicone Block Large - SoftInternational Medical Devices, Inc. · Elastomer, Silicone Block9 reports
- Himplant Pre-Formed Penile Silicone Block Extra Large - Extra Long - SoftInternational Medical Devices, Inc. · Elastomer, Silicone Block7 reports
- Himplant Pre-Formed Penile Silicone Block Large - Extra Long - SoftInternational Medical Devices, Inc. · Elastomer, Silicone Block7 reports
- ContourFlex™ Gluteal Implant, Anatomical (Teardrop) Size 3Implantech Associates, Inc. · Elastomer, Silicone Block3 reports
- Gluteal Implant, Round, Textured, SDM Size: 14.9cm x 14.9cm x 3.9cmImplantech Associates, Inc. · Elastomer, Silicone Block2 reports
- ContourFlex™ Gluteal Implant, Round (Natural Contour) Size 3Implantech Associates, Inc. · Elastomer, Silicone Block2 reports
- ContourFlex™ Gluteal Implant, Anatomical (Teardrop) Size 2Implantech Associates, Inc. · Elastomer, Silicone Block2 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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