INHANCE 6205-10-107Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295539445), received between Apr 28, 2023 and Sep 17, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (10 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.

• MalfunctionSep 17, 2026Device-Device Incompatibility

  It was reported that during extraction, the shell taper adapter became stuck on the star drive 30. The reporter were not able to get them separated.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50801245 ↗
• MalfunctionMay 20, 2026Material Deformation

  IT WAS REPORTED THAT DURING A SHOULDER REPAIR SURGICAL PROCEDURE, THE EXTRACTION TIP CROSS THREADED INTO HUMERAL SHELL THAT WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25234187 ↗
• MalfunctionJan 13, 2026Material Deformation

  IT WAS REPORTED THAT THE DRIVE SHAFT BEARING WAS BROKEN AND THE EXTRACTOR TAPER SHELL WAS STRIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24054512 ↗
• MalfunctionOct 16, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE THREADS WERE STRIPPED OF THE INSTRUMENT AND NEEDS TO BE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23312054 ↗
• MalfunctionJul 28, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THERE WAS A STRIPPED EXTRACTOR TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22630150 ↗
• MalfunctionMar 11, 2025Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SHOULDER INSTRUMENTS ARE BROKEN, BENT, AND STRIPPED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21575815 ↗
• MalfunctionMar 11, 2025Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SHOULDER INSTRUMENTS ARE BROKEN, BENT, AND STRIPPED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21575812 ↗
• MalfunctionMar 11, 2025Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SHOULDER INSTRUMENTS ARE BROKEN, BENT, AND STRIPPED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21575811 ↗
• MalfunctionMar 11, 2025Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SHOULDER INSTRUMENTS ARE BROKEN, BENT, AND STRIPPED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21575810 ↗
• MalfunctionMar 11, 2025Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SHOULDER INSTRUMENTS ARE BROKEN, BENT, AND STRIPPED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21575807 ↗
• MalfunctionNov 20, 2024Material Deformation; Material Deformation

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: NO ADVERSE EFFECTS OR DELAYS TO REPORT.

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

  MAUDE report 20736479 ↗
• MalfunctionMay 9, 2024Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  DURING AN INHANCE SHOULDER PROCEDURE, HAD TO REMOVE THE BOTH A IMPLANT SHELL AND LINER, IN ORDER TO DO SO THE THREADED TIP EXTRACTOR/TAPER SHELL EXTRACTOR TIP WAS UTILIZED. BOTH WERE ATTACHED TO TWO CANNULATED IMPACTOR HANDLES TO REMOVE IT, UNFORTUNATELY A LOT OF TORQUE WAS REQUIRED TO REMOVE IT WHICH CAUSED THE THIN THREADS OF THE INSTRUMENTS TO GET DAMAGE AND UNUSABLE. IN ADDITION THE BASEPLATE INSERTER ROD THREADS AND ONE GLENOSPHERE INSERTER TIP WERE DAMAGED AGAIN TO THIN THREADS WHILE TRYING TO IMPACT THE GLENOSPHERE INTO THE BASE PLATE. THERE WAS NO SURGICAL DELAY. A SECOND SET OF INSTRUMENTS WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19277079 ↗
• MalfunctionApr 28, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THREADS ON THE INSTRUMENT ARE STRIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16833881 ↗