INHANCE 5507-06-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295546948), received between Feb 6, 2024 and Aug 27, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE THREAD ON THE KICKSTAND WOULD NOT LOCK IN THE BASEPLATE. DOE: (B)(6) 2025. AFFECTED SIDE: UNKNOWN SHOULDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22906733 ↗
• MalfunctionOct 23, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE LEFT REVERSE TSA FOR HUMERAL SIDED REVISION, GLENOID EROSION. THE ENHANCE GLENOID WAS PREPPED FOR A 6MM KICKSTAND VIA SURGICAL TECHNIQUE. KICKSTAND IMPLANT WOULD NOT SCREW INTO BASEPLATE. ANOTHER KICKSTAND IMPLANT WAS OPENED AND INSERTED AFTER REDRILLING FOR A 6MM AUGMENT.

  Patient problems: Insufficient Information

  MAUDE report 20513389 ↗
• MalfunctionSep 6, 2024Difficult to Insert; Naturally Worn; Difficult to Insert; Naturally Worn

  ADDITIONAL INFORMATION WAS RECEIVED: A. WAS THERE ANY PATIENT HARM RELATED TO THE EVENT? NO PATIENT HARM DUE TO EVENT. B. WAS THERE ANY SURGICAL DELAY RELATED TO THE EVENT? YES, THERE WAS A 15 MINUTE DELAY DUE TO EVENT. C. IS THERE ANY PATIENT CONSEQUENCE AGAINST THE REPORTED PRODUCT? YES, AUGMENT WAS UNABLE TO BE USED. AS A RESULT, SURGEON ESTIMATED THAT GLENOID COVERAGE WAS AT APPROXIMATELY 80%, THUS WARRANTING THE NEED FOR AUGMENTATION THAT WAS UNFORTUNATELY UNABLE TO BE PERFORMED. D. WAS THERE ANY ALLEGATION WITH THE BASEPLATE/METAGLENE? NO ALLEGATION WITH THE BASEPLATE. THE CENTRAL SCREW AND PERIMETER LOCKING SCREWS THAT WERE USED WENT IN WITH NO ISSUES AND APPEARED TO ENGAGE PROPERLY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20155645 ↗
• MalfunctionAug 15, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE AUGMENT ON DEMAND WAS PREPPED VIA SURGICAL PROTOCOL. KICKSTAND IMPLANT WOULD NOT ENGAGE THREADS OF IMPLANT. SECOND IMPLANT WAS PUT IN SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 19990086 ↗
• MalfunctionJul 2, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE SCREW STRIPPED OUT. AFTER 2 ATTEMPTS, A NEW SCREW WAS USED AND PROCEDURE WAS COMPLETED SUCCESSFULLY. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Insufficient Information

  MAUDE report 19656299 ↗
• MalfunctionMay 2, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE PATIENT HAD A RIGHT RTSA, SURGEON COULD NOT GET KICKSTAND IMPLANT TO DEFINITIVELY LOCK IN BASEPLATE. REPORTED A 5 MINUTE DELAY AS THEY ATTEMPTED TO RE-DRILL, RE INSERT AND FINALLY OPENED ANOTHER IMPLANT WHICH LOCKED INTO THE BASE PLATE ON FIRST ATTEMPT. DOE: (B)(6) 2024 AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19228391 ↗
• MalfunctionFeb 6, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE AUGMENT WOULD NOT SCREW INTO THE BASEPLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18652857 ↗