INHANCE 6500-32-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10603295547280), received between Jan 24, 2023 and Sep 18, 2026 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Break” (13 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Break

  It was reported that upon inspection of the 32 +0 trial poly, one of the locking tabs was missing. Another set was opened so the surgeon could trial the range of motion. No additional time was added to the surgery, and the broken trial was removed. Another instrument in the tray still had a baseplate attached from a removal surgery performed the week prior. The implant could not be removed, so SPD processed the instrument assembled. The tray was replaced with another tray that was available at the account. All available information has been disclosed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50819619 ↗
• MalfunctionJun 17, 2026Break

  IT WAS REPORTED THAT WHEN TAKING APART THE TRIAL LINER AND SHELL, ONE OF THE TABS BROKE OFF THE LINER TRIAL AND THE DOCTOR REQUESTED IT TO BE REPLACED. DOI: UNKNOWN. DOR: UNKNOWN. AFFECTED SIDE: RIGHT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25534061 ↗
• MalfunctionMar 18, 2026Break

  IT WAS REPORTED THAT THE LOCKING MECHANISM WAS SHEARED OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24629493 ↗
• MalfunctionFeb 18, 2026Break

  IT WAS REPORTED THAT DURING SHOULDER REPAIR SURGERY, THE 32+0 REVERSE TRIAL LINER WAS BROKEN WHILE REMOVING FROM THE SHELL TRIAL ON BACK TABLE. THERE WAS NO DELAY TO SURGERY AND THE PATIENT WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24377460 ↗
• MalfunctionJan 7, 2026Break

  IT WAS REPORTED THAT TRIAL LINER WAS DISCOVERED BROKEN BEFORE START OF CASE. THERE WAS NO DELAY OR EXTENDED SURGICAL TIME. CASE WAS COMPLETED WITHOUT INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23990258 ↗
• MalfunctionJul 29, 2025Break; Break

  IT WAS REPORTED THAT WHEN THE SURGEON WENT TO TAKE THE TRIAL POLY OFF OF THE STEM AFTER TRIALING, A PLASTIC TAB BROKE OFF THE TRIAL POLY. THERE WERE 2 PIECES AND BOTH WERE COLLECTED. THERE WAS NO DELAY TO THE CASE OR PATIENT CONSEQUENCE AS THE REPORTER DID TRIALING, AND THE PIECES WERE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22644521 ↗
• MalfunctionJul 28, 2025Break; Break

  IT WAS REPORTED THAT THE TRIALS WERE CHIPPING. QUALITY ISSUE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22632571 ↗
• MalfunctionOct 31, 2024Break; Break

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 20577145 ↗
• MalfunctionJan 29, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE 46X16 HAS A BROKEN TAB AND THE TRIAL OFFSET ADAPTER WILL NOT STAY IN THE HEAD. 32+0 POLY TRIAL WILL NOT STAY IN THE +8 SPACER.

  Patient problems: Insufficient Information

  MAUDE report 18594997 ↗
• MalfunctionJan 22, 2024Break; Break

  IT WAS REPORTED THAT THE SMALL GLENOID REAMER WAS CHIPPED UP, AND COULD NOT BE FULLY DECONTAMINATED. UPON INSPECTION IT IS DAMAGED AROUND THE PERIPHERAL RING WITH SPOTS THAT ARE NO LONGER SMOOTH, AND INSTEAD ROUGH. IT HAD BEEN REMOVED FROM THE SET. THE 32+0 POLY ALSO HAD CHIPS IN IT AND NEEDED TO BE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18552093 ↗
• MalfunctionNov 6, 2023Break; Break

  IT WAS REPORTED THAT THE TRIAL BROKE IN HALF WHEN BEING TAKEN OUT POST TRIAL REDUCTION. UNKNOWN SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18078750 ↗
• MalfunctionJul 24, 2023Break; Break

  IT WAS REPORTED THAT THE DEVICE WAS FOUND BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17378655 ↗
• MalfunctionApr 4, 2023Break; Break

  IT WAS REPORTED THAT A TRIAL WAS PERFORMED WITH THE 32 +0 REVERSE LINER AND THE TABS THAT LOCK IT INTO THE HUMERAL SHELL TRIAL HAD BROKEN. THE POLY TRIAL WOULD NOT STAY LOCKED INTO THE HUMERAL SHELL TRIAL. THE SURGEON ASKED TO REPLACE THE TRIAL. ALL PARTS WERE RETRIEVED FROM THE PATIENT. THERE WAS NO DELAY DUE TO BROKEN INSTRUMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16674477 ↗
• MalfunctionMar 29, 2023Break; Scratched Material; Break; Scratched Material

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE INSTRUMENT DID NOT BREAK INTO TWO OR MORE PIECES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16634485 ↗
• MalfunctionJan 24, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THE TRIAL WAS NOT PROPERLY SEATING AS IT NORMALLY DOES. THERE WAS NO SURGICAL DELAY. NO ADVERSE AFFECTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16234445 ↗