INHANCE 5200-40-157Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295538318), received between Dec 9, 2022 and Sep 11, 2026 — classified as 6 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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 6 most recent of 6 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 50730876 ↗
• InjuryApr 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANTS CONVERTED TO REVERSE DUE TO CUFF TEAR. DOI- (B)(6) 2025. DOR- (B)(6) 2026. AFFECTED SIDE- RIGHT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 25001165 ↗
• InjuryNov 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FROM ANATOMIC HEMI TO REVERSE-FAILED CUFF. NO FAILED IMPLANT, NO FAILED IMPLANT, ALL PIECES OF HEAD AND ADAPTER REMOVED. USER COULD NOT READ LOT NUMBER ON IMPLANTS. RIGHT SHOULDER WAS AFFECTED. IMPLANTED IN THE CITY IN 2023. USER WAS UNSURE OF HOSPITAL, DATE, SURGEON. NO OTHER INFORMATION KNOWN. THERE WAS NO DELAY. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23633224 ↗
• InjuryAug 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO FAILED SUBSCAP REPAIR FOLLOWING TSA. REVISED TO REVERSE SHOULDER. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 22914387 ↗
• InjuryApr 4, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT DISLOCATED POSTERIORLY AND NEEDED A REVISION FROM AN ANATOMIC SHOULDER TO A REVERSE SHOULDER. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 21780257 ↗
• InjuryDec 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO STABILITY ISSUES THAT WERE NOT IMPLANT RELATED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. RIGHT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 15952092 ↗