INHANCE 6500-40-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295547396), received between Mar 16, 2023 and Feb 12, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 12, 2026Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT DURING SURGERY WHILST TRIALING , OUR TRIAL POLYS WERE NOT ATTACHING WELL TO THE SHELL TRIAL. TECH POINTED OUT THE LOCKING TAB MECHANISMS WERE BENT AND NOT FULLY ENGAGING. AFTER INSPECTION, THE TRIALS WERE FULLY INTACT AND NOTHING WAS BROKEN, JUST BENT, THEREFORE NOT LEAVING ANYTHING INTO BODY. NO ADVERSE AFFECTS TOWARDS THE PATIENT AND NO TIME WAS LOST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24321910 ↗
• MalfunctionDec 17, 2025Break; Break

  IT WAS REPORTED THAT AFTER TRIAL REDUCTION THE SURGEON WAS REMOVING THE TRIAL POLYETHYLENE INSERT WHEN THE SMALL LOCKING CLIP BROKE OFF. ALL PIECES WERE RETRIEVED, AND THERE WAS NO DELAY TO THE PROCEDURE OR HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23827160 ↗
• MalfunctionJun 24, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SHOULDER REPAIR SURGERY, AND THE LOCKING MECHANISM ON THE ITEM BROKE. POLY WON¿T SIT PROPERLY INTO SHELL TRIALS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22318025 ↗
• MalfunctionMay 5, 2025Break; Break

  IT WAS REPORTED THAT THE TAB BROKE OFF OF THE LINER TRIAL WHILE REMOVING. ALL PIECES WERE RETRIEVED. NO SURGICAL DELAY. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21961069 ↗
• MalfunctionApr 22, 2025Break; Break

  IT WAS REPORTED THAT WHILE GOING THROUGH INSTRUMENTS TO TURN THEM OVER FOR CASES, IT WAS NOTICED THAT THESE INSTRUMENTS WERE ALL BROKEN AND NEEDED TO BE REPLACED. THERE WERE NO DELAYS OR ADVERSE EVENTS THAT TOOK PLACE FOR ANY OF THE DOCTOR'S CASES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21881417 ↗
• MalfunctionNov 6, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL SHOULDER REPLACEMENT ON (B)(6) 2024. THE POLY TRIAL CRACKED WHEN SEPARATING FROM THE SHELL TRIAL AT THE BACK TABLE. ALL PARTS WERE RETRIEVED AND NO DELAY WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 20625158 ↗
• MalfunctionApr 26, 2024Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT AFTER RESPECTING THE HUMERAL HEAD AND IMPLANTING THE TRIAL STEM THE SURGEON SIZED THE HEAD RESECTION, SNAPPED THE ADAPTER AT C AND TURNED CLOCKWISE TO H OFFSET. WHEN WENT TO PLACE FROM TRIALING IT CAME LOOSE. WHEN BROUGHT TO BACK TABLE IT WAS NOTICED SMALL TEETH LIKE PIECES INSIDE OF HEAD WERE SNAPPED OFF. THE PROCESS WAS DONE AGAIN WITH ONE SIZE UP HUMERAL HEAD, THE SAME THING HAPPENED. HE THEN MOVED ONTO PREPARING THE GLENOID AND ONCE PREPARED HE DECIDE ON A REVERSE. HE HAD NO ISSUES WITH BASEPLATE OR TRIAL GLENOSPHERE. HE ALIGNED THE LINES ON THE +0 SHELL TRIAL AND THE 40+0R POLY AND AN AUDIBLE SNAP WAS HEARD. HE THEN PLACED THAT CONSTRUCT ON THE STEM AND THE POLY WOULD NOT STAY SNAPPED IN PLACE AND DISSOCIATED ONCE THROUGH TRIALING THROUGH ROM THUS CREATING A MINOR DELAY IN SURGICAL PROCEDURE. DOCTOR WAS SATISFIED WITH OVERALL RANGE OF MOTION AND X-RAYS OF OVERALL PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 19190450 ↗
• MalfunctionNov 30, 2023Break; Break

  IT WAS REPORTED THAT THE STERILE PROCESSING TECH INFORMED THAT A TAB FROM THE 40MM POLY TRIAL BROKE OFF. THIS DID BREAK INTO 2 PIECES, AND HAPPEN POST OP SO THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18238388 ↗
• MalfunctionMar 16, 2023Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT THE 40 +0 POLY TRIAL WOULD NOT STAY ENGAGED IN THE HUMERAL SHELL TRIAL WHEN TRIAL REDUCING THE SHOULDER. SAME THING HAPPENED WITH THE 40 +0 RETENTIVE TRIAL AS WELL. WHEN THE SURGEON LOOKED AT THE POLY TRIALS, HE MENTIONED THE TABS THAT LOCK INTO THE HUMERAL SHELL TRIAL WERE BROKEN. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16552763 ↗