INHANCE 6500-40-104Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295547419), received between Sep 5, 2025 and Sep 25, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (3 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Device-Device Incompatibility; Scratched Material

  It was reported that during a Shoulder Repair trial reduction of the shoulder, the surgeon informed that the poly trial was disassociating from the shell trial. The representative noticed the poly was pretty scratched up and the tabs to click into the shell trial were damaged. All parts were retrieved. There were no delays or adverse events that took place.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50897306 ↗
• MalfunctionFeb 12, 2026Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT DURING SURGERY WHILST TRIALING, OUR TRIAL POLYS WERE NOT ATTACHING WELL TO THE SHELL TRIAL. TECH POINTED OUT THE LOCKING TAB MECHANISMS WERE BENT AND NOT FULLY ENGAGING. AFTER INSPECTION, THE TRIALS WERE FULLY INTACT AND NOTHING WAS BROKEN, JUST BENT, THEREFORE NOT LEAVING ANYTHING INTO BODY. NO ADVERSE AFFECTS TOWARDS THE PATIENT AND NO TIME WAS LOST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24321769 ↗
• MalfunctionSep 11, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT THE TABS ON TRIAL LINERS WERE BROKEN AND THEY WOULD NOT STAY LOCKED IN TO SHELL TRIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23026524 ↗
• MalfunctionSep 5, 2025Break; Break

  IT WAS REPORTED THAT THE TRIAL LINER SHELL TAB WAS BROKEN AND NOTICED AFTER TRIALING BETWEEN MULTIPLE RETENTIVE AND REGULAR LINERS. AS WELL AS THE 30 STAR DRIVE WENT THRU SETS AND BOTH WERE STRIPPED AFTER PREVIOUS USAGE OF IMPLANTATION OF GLENOSHOHERES. IT CAUSED ISSUES WHEN REMOVING THE GLENOSPHERE FOR THE REVISION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22976282 ↗