INHANCE 6200-44-152Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295539193), received between Mar 3, 2023 and Jul 27, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Break” (11 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.

• MalfunctionJul 27, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50019620 ↗
• MalfunctionApr 8, 2026Break; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING REASSEMBLY OF THE TRAYS FOR A TOTAL SHOULDER REPLACEMENT SURGERY, IT WAS OBSERVED THAT THE LOCKING TABS ON THE HEAD TRIAL (44X15.25) WHERE BROKEN AND LOSE. THE HEAD ADAPTER WOULD NO LONGER LOCK INTO TRIAL. THERE WAS NO HARM TO PATIENT AND NO SURGICAL DELAY, ALL BROKEN PIECES WHERE RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24818886 ↗
• MalfunctionJan 7, 2026Break

  IT WAS REPORTED THAT DURING A TOTAL SHOULDER REPLACEMENT SURGICAL PROCEDURE, THE FEMORAL HEAD TABS WERE BROKEN AFTER SURGERY. ALL OF THE PIECES WERE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23989743 ↗
• MalfunctionSep 9, 2025Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL SHOULDER REPLACEMENT AND THE TABS WERE BROKEN ON THE ITEM. THE DEVICE BROKE INTO THREE PIECES AND ALL PIECES WERE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23005637 ↗
• MalfunctionJul 8, 2025Break; Break

  IT WAS REPORTED THAT STAFF NOTICED THAT THE TEETH ON THE BOTTOM OF THE 44 HEAD TRIALS WERE BROKEN OFF. NO PIECES WERE IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22441715 ↗
• MalfunctionJun 30, 2025Break; Break

  IT WAS REPORTED THAT THE TRIALS HAVE BROKEN PARTS ON THE BOTTOM, AND THE GLENOSPHERE TIP WAS INTERNALLY STRIPPED. THE EVENT DID NOT HAPPENED DURING A SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22357525 ↗
• MalfunctionDec 26, 2024Break; Break

  IT WAS REPORTED THAT THE INSTRUMENT WAS BROKEN. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 21019615 ↗
• MalfunctionAug 9, 2024Break; Break

  IT WAS REPORTED THAT THE THE PLASTIC TABS ON THE UNDERSIDE OF THE HUMERAL HEADS WERE BROKEN. THIS MADE IT DIFFICULT TO GET THE HUMERAL PIN GUIDE TO ENGAGE INTO THE HEAD TRIAL FOR THE CASE. NO DELAYS OR ADVERSE EVENTS TOOK PLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19950549 ↗
• MalfunctionApr 26, 2024Break; Break

  IT WAS REPORTED THAT THE TINES ON THE INSIDE OF THE HEAD TRIAL BROKE OFF WHILE THE TECH WAS TURNING THE HUMERAL HEAD ADAPTER TRIAL.

  Patient problems: Insufficient Information

  MAUDE report 19190322 ↗
• MalfunctionMar 13, 2024Break; Break

  IT WAS REPORTED THAT THE PLASTIC TINES INSIDE THE HEAD TRIAL BROKE OFF WHILE REMOVING THE HUMERAL HEAD ADAPTER FROM THESE 2 TRIAL HEADS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18894686 ↗
• MalfunctionOct 23, 2023Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT THE HUMERAL HEAD ADAPTER HAS A CRACK AND WILL NOT ENGAGE. THERE WAS NO SURGICAL DELAY DURING CASE AND NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17985893 ↗
• MalfunctionMar 3, 2023Break; Break

  IT WAS REPORTED THAT THE HUMERAL PIN GUIDE WAS GOING TO BE USED FOR PLACEMENT OF THE HUMERAL PIN AND THE PIN GUIDE WOULD NOT STAY IN THE 46X16 HEAD TRIAL. THAT WAS WHEN THE SURGEON NOTICED THAT THE TABS IN THE HEAD TRIAL WERE BROKEN. WHEN LOOKING TO GRAB A DIFFERENT HEAD TRIAL, IT WAS NOTICED THAT THE TABS WERE BROKEN ON THE 44X15.25 HEAD TRIAL AS WELL. ALSO, WHEN PREPPING THE HUMERAL SIDE FOR A SHORT STEM, ONE OF THE PINS FROM THE HUMERAL PIN PUNCH BROKE OFF. THERE WAS A SURGICAL DELAY OF 5 MINUTES.

  Patient problems: Insufficient Information

  MAUDE report 16478153 ↗