INHANCE 5507-08-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295546955), received between Sep 6, 2024 and Nov 12, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Insert” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 12, 2024Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE GLENOID COMPONENT FAILED. THERE WAS LOOSENING OF THE GLENOSPHERE AND BASEPLATE. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Inadequate Osseointegration

  MAUDE report 20662954 ↗
• MalfunctionSep 6, 2024Difficult to Insert; Naturally Worn; Difficult to Insert; Naturally Worn

  WAS THERE ANY PATIENT HARM RELATED TO THE EVENT? NO PATIENT HARM DUE TO EVENT. WAS THERE ANY SURGICAL DELAY RELATED TO THE EVENT? YES, THERE WAS A 15 MINUTE DELAY DUE TO EVENT. 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. 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 20155647 ↗