INHANCE 6105-10-050Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295538844), received between Aug 3, 2022 and Jan 21, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Break” (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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 21, 2026Crack

  IT WAS REPORTED THAT DEPTH GAUGE CRACKED AND GLENOID TRIAL CRACKED. IT WAS REPORTED THAT THE EVENT DID NOT OCCUR IN A SURGICAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24141532 ↗
• MalfunctionDec 30, 2025Break; Break

  IT WAS REPORTED THAT DURING A TOTAL SHOULDER REPLACEMENT SURGICAL PROCEDURE, THE LARGE GLENOID SIZER FELL TO THE FLOOR AND WAS BROKEN WHEN FOUND. THE PATIENT WAS NOT AFFECTED AND THERE WAS NO DELAY TO SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23927477 ↗
• MalfunctionAug 22, 2025Crack; Crack

  IT WAS REPORTED THAT THE LARGE HUMERAL SIZER DISK AND LARGE GLENOID SIZER DISK WERE CRACKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22873355 ↗
• MalfunctionAug 7, 2025Crack; Crack

  IT WAS REPORTED THAT THE LARGE GLENOID SIZER DISC CRACKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22736504 ↗
• MalfunctionJul 18, 2025Break; Break

  IT WAS REPORTED THAT THE LARGE ANATOMIC GLENOID SIZER WAS DROPPED AND BROKE. THERE WAS NO DELAY TO SURGERY AND THE PATIENT WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22545795 ↗
• MalfunctionOct 30, 2024Break; Break

  IT WAS REPORTED THAT CUTTING GUIDE WOULD NOT ACCEPT PINS AND SEEMS WARPED. XS HUMERAL SIZER BROKE, L AND XL GLENOID SIZER ALSO BROKE.

  Patient problems: Insufficient Information

  MAUDE report 20571530 ↗
• MalfunctionAug 27, 2024Break; Break

  IT WAS REPORTED THAT THE MEASURING INSTRUMENTS WERE BROKEN.

  Patient problems: Insufficient Information

  MAUDE report 20075652 ↗
• MalfunctionAug 27, 2024Break; Break

  IT WAS REPORTED THAT THE MEASURING INSTRUMENTS WERE BROKEN.

  Patient problems: Insufficient Information

  MAUDE report 20075632 ↗
• MalfunctionAug 27, 2024Break; Break

  IT WAS REPORTED THAT THE MEASURING INSTRUMENTS WERE BROKEN.

  Patient problems: Insufficient Information

  MAUDE report 20075615 ↗
• MalfunctionMar 28, 2024Crack; Crack

  IT WAS REPORTED THAT THERE WAS A CRACK GOING THROUGH THE TRIAL. THIS HAPPENED POST OP SO THERE WAS NO NEGATIVE IMPACT TO THE PATIENT NOR WAS SURGERY TIME EXTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19000336 ↗
• MalfunctionJul 14, 2023Crack; Crack

  IT WAS REPORTED THAT DURING PRIMARY REVERSE TOTAL SHOULDER ARTHROPLASTY, THE LARGE GLENOID SIZER WAS CRACKED. NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17328069 ↗
• MalfunctionMay 11, 2023Crack; Crack

  IT WAS REPORTED THAT THE SIZER CRACKED. NO PARTS WERE IN THE SURGICAL FIELD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16911037 ↗
• MalfunctionAug 3, 2022No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE INHANCE GLENOID SIZERS GET LOST AT A RATE THAT FAR EXCEEDS NORMAL INSTRUMENTATION. THE SURGEON NEEDED THE SIZERS FOR THEIR CASES BUT ITS DIFFICULT WHEN THESE SIZERS ARE CONSTANTLY MISSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15158104 ↗