INHANCE 6201-01-161Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295539353), received between May 9, 2023 and Sep 23, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (5 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50874727 ↗
• MalfunctionJun 24, 2026Material Deformation

  IT WAS REPORTED THAT THREADS ON STEM ADAPTOR WERE STRIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25609840 ↗
• MalfunctionApr 29, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE INSERTER IMPACTOR BROKE INTO THE THREADS OF THE STEM INSERTER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25035640 ↗
• MalfunctionJun 26, 2025Break; Break

  IT WAS REPORTED THAT THE SCREWDRIVERS ARE STRIPPED, THE INSERTER HANDLE BROKE, AND THE GLENOID REAMER BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22341212 ↗
• MalfunctionMar 21, 2025Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT THE DEVICES WERE BROKEN AND STRIPPED THREAD. SURGICAL DELAY WAS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 21667804 ↗
• MalfunctionJan 7, 2025Break; Break

  IT WAS REPORTED THAT THERE WAS A BROKEN ITEM. IT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21092622 ↗
• MalfunctionSep 23, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT AFTER FINISHING THE PROCEDURE ON (B)(6) 2023, THE SCRUB TECH WAS TAKING APART THE INSTRUMENTS AND AS SHE WAS PULLING OFF THE VERSION ROD, A PART OF THE PLASTIC SNAPPED OFF THIS AND IT BROKE INTO TWO PIECES. AS SHE WAS TAKING IT OFF, IT WAS ALSO NOTICED THAT A SMALL CRACK WAS BEGINNING TO FORM IN THE WHITE PORTION OF THE STEM INSERTER. THIS HAPPENED AFTER IMPLANTATION WAS COMPLETED AND SURGERY WAS FINISHED, SO THERE WAS NO NEGATIVE IMPACT TO THE PATIENT NOR WAS SURGERY TIME EXTENDED DUE TO THIS MALFUNCTION. IT WAS FURTHER REPORTED DURING THE INVESTIGATION THAT THE ACTUAL MALFUNCTION OF THE STEM INSERTER BOLT HEXALOBULAR DRIVE WAS STRIPPED. THERE IS NO ALLEGATION OF CRACKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20280824 ↗
• MalfunctionAug 14, 2024Crack; Naturally Worn; Crack; Naturally Worn

  IT WAS REPORTED THAT WHILE INSPECTING INSTRUMENTS IT WAS NOTICED THAT MULTIPLE ITEMS ARE CRACKED/ HAVE WORN THREADS. THE EVENT DID NOT HAPPEN DURING A SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19983677 ↗
• MalfunctionAug 14, 2024Crack; Naturally Worn; Crack; Naturally Worn

  IT WAS REPORTED THAT WHILE INSPECTING INSTRUMENTS IT WAS NOTICED THAT MULTIPLE ITEMS ARE CRACKED/ HAVE WORN THREADS. THE EVENT DID NOT HAPPEN DURING A SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19983587 ↗
• MalfunctionJan 18, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE THREADS ON GLENOSPHERE INSERTER TIP ARE STRIPPED. THE EVENT DID NOT OCCUR DURING SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18537933 ↗
• MalfunctionNov 3, 2023Break; Break

  IT WAS REPORTED THAT THE THREADED PIECE BROKE OFF. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18064454 ↗
• MalfunctionMay 9, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT DURING THE SURGICAL PROCEDURE, WHILE IMPACTING THE IMPLANT LINER THE REVERSE IMPACTOR PUCK CRACKED. NO PARTS WERE BROKEN OFF INTO THE SURGICAL FIELD. ALSO, WHILE ATTACHING THE HUMERAL STEM TO THE STEM INSERTER BOLT, THE THREADS ON THE STEM GOT CROSS THREADED. THERE WAS NO DAMAGE TO THE HUMERAL IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16898857 ↗