INHANCE 6500-36-004Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295547365), received between Feb 5, 2024 and Sep 21, 2026 — classified as 8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50845105 ↗
• MalfunctionMar 18, 2026Break

  IT WAS REPORTED THAT THE LOCKING MECHANISM WAS SHEARED OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24632251 ↗
• MalfunctionMar 18, 2026Break

  IT WAS REPORTED THAT THE LOCKING MECHANISM WAS SHEARED OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24626407 ↗
• MalfunctionDec 17, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT TKA FOR OA WITH A IMPACTOR IN QUESTION. DURING IMPACTION ON FEMUR, THE IMPACTOR BROKE. AFTER THE BREAKAGE, THE IMPACTOR WAS NOT USED, AND THE FRAGMENT WAS RETRIEVED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23826975 ↗
• MalfunctionDec 17, 2025Break; Break

  IT WAS REPORTED THAT DURING A REVERSE TOTAL SHOULDER ARTHROPLASTY, THE SURGEON NOTED THAT BOTH THE 36+0 AND 36+4 REVERSE LINER TRIALS WERE BROKEN. EACH OF THEM HAD A BROKEN LOCKING TAB SUCH THAT THEY DIDN'T STAY IN THE REVERSE SHELL TRIAL. THERE WERE NO BROKEN PIECES AS THE INSTRUMENT APPEARS TO HAVE BEEN BROKEN BEFORE SURGERY BEGAN. THERE WAS NO DELAY OR COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23826823 ↗
• MalfunctionJan 15, 2025Break; Material Deformation; Scratched Material; Break; Material Deformation; Scratched Material

  IT WAS REPORTED THAT RETENTION TABS ON REVERSE LINER TRIALS ARE COMPROMISED AND NO LONGER FUNCTIONAL DUE TO GOUGING, SHEARED OFF, OR BENT OUT OF PROPER SHAPE. EVENT OCCURRED DURING POST-OP RESET AND INSPECTION. THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21159763 ↗
• MalfunctionAug 22, 2024Break; Break

  IT WAS REPORTED THAT THE TAB IS BROKEN. THE EVENT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20030122 ↗
• MalfunctionFeb 5, 2024Break; Break

  IT WAS REPORTED THAT THE LOCKING TAB BROKE OFF OF THE INSTRUMENT. ALL PARTS WERE RETRIEVED FROM THE PATIENT AND NO TIME WAS ADDED TO THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18644828 ↗