INHANCE 6200-54-190Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295539278), received between Jan 2, 2025 and Jul 27, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 27, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50019677 ↗
• MalfunctionFeb 17, 2026Break

  ADDITIONAL INFORMATION STATES THAT THEY BROKE AT THE BASE DUE TO WEAR OVER TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24368561 ↗
• MalfunctionAug 27, 2025Break; Break

  IT WAS REPORTED THAT DURING THE CASE, THE PRONGS ON THE BACK OF THE ANATOMIC HEAD TRIAL WERE BROKEN. A SMALL AND MEDIUM GLENOID TRIAL WAS CRACKED ALONG WITH THE ANATOMIC ADAPTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22905282 ↗
• MalfunctionJul 3, 2025Break; Break

  IT WAS REPORTED THAT THE TWO 54X19 INHANCE HEAD TRIALS INNER TINES SNAPPED OFF ON THE BACK TABLE WHILE TRYING TO INSERT THE TAPER ADAPTOR TRIAL. THERE WERE NO PIECES LEFT IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22396934 ↗
• MalfunctionJul 3, 2025Break; Break

  IT WAS REPORTED THAT THE TWO 54X19 INHANCE HEAD TRIALS INNER TINES SNAPPED OFF ON THE BACK TABLE WHILE TRYING TO INSERT THE TAPER ADAPTOR TRIAL. THERE WERE NO PIECES LEFT IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22396929 ↗
• MalfunctionJan 3, 2025Break; Break

  IT WAS REPORTED THAT WHEN ADJUSTING THE TRIAL ADAPTER, TWO PLASTIC TABS BROKE OFF THE 54X19 HEAD TRIAL. NO DELAYS OR ADVERSE EVENTS TOOK PLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21069137 ↗
• MalfunctionJan 3, 2025Break; Break

  IT WAS REPORTED THAT WHEN ADJUSTING THE TRIAL ADAPTER, TWO PLASTIC TABS BROKE OFF THE 54X19 HEAD TRIAL. THERE WERE NO DELAYS OR ADVERSE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21069064 ↗
• MalfunctionJan 2, 2025Break; Break

  IT WAS REPORTED THAT WHEN ADJUSTING THE TRIAL ADAPTER, TWO PLASTIC TABS BROKE OFF THE 54 X 19 HEAD TRIAL. THERE WAS NO DELAYS OR ADVERSE EVENTS TOOK PLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21063022 ↗