INHANCE 5100-21-500Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295538172), received between Jun 20, 2023 and Sep 11, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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. How this data works · Data updated Oct 13, 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.

• InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem

  Patient had an anatomic total shoulder done in (b)(6) 2023. Rotator cuff has since failed so we converted her to a reverse shoulder.DOI: (b)(6) 2023.DOR: (b)(6) 2026.Affected Side: Left Shoulder.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 50730738 ↗
• InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that soft tissue failed. No mechanical issue with implants.DOI: (b)(6) 2026.DOR: (b)(6) 2026.Affected side: Unknown.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 50053646 ↗
• InjuryApr 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANTS NEEDED TO BE REVISED TO A REVERSE DUE TO INSUFFICIENT ROTATOR CUFF. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24769604 ↗
• InjuryFeb 25, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED WITH THE CONVERSION OF SHOULDER FROM ANATOMIC TO REVERSE DUE TO ROTATOR CUFF FAILURE. NO OTHER INFORMATION KNOWN AT THIS TIME. DOI: (B)(6) 2022, DOR: (B)(6) 2026, AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24445727 ↗
• InjuryJan 14, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT TOTAL SHOULDER CONVERSION FROM ANATOMIC TO REVERSE ARTHROPLASTY RELATED TO GLENOID IMPLANT DISASSOCIATED. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 24066683 ↗
• InjuryNov 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO SUBSCAPULAR FAILURE. THERE WAS CONVERSION TO REVERSE TOTAL SHOULDER. DOI: UNKNOWN. DOR: (B)(6)2023. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 18055618 ↗
• InjuryJul 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A LEFT TSA WITH INHANCE STEMLESS AND GLENOID. AT THAT TIME THE CASE WAS SCHEDULED AS TSA VS RTSA DUE TO THE QUALITY OF THE SUBSCAP. IT WAS DECIDED THE SUBSCAP HAD FAILED AND THE PATIENT HAD EXPLANATION OF INHANCE TSA, ALL COMPONENTS, WITH CONVERSION TO ARTHREX REVERSE TSA. DOI: (B)(6) 2023; DOR: (B)(6) 2023; AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17309496 ↗
• InjuryJun 20, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO DISLOCATION/INSTABILITY FOLLOWING TOTAL SHOULDER REPLACEMENT. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 17164840 ↗