INHANCE 5200-46-185Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295538370), received between Oct 2, 2023 and Sep 17, 2026 — classified as 7 injuries.

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient had an injury to her cuff. The doctor chose to convert to reverse.Affected Side: Right Shoulder.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 50806072 ↗
• InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient underwent a failed rotator cuff conversion to reverse total shoulder arthroplastyDOI: (b)(6) 2025.DOR: (b)(6) 2026.Affected side: Left shoulder.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 50696055 ↗
• InjuryFeb 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THE SHOULDER REVISION PROCEDURE DURING WHICH THE SURGEON REMOVED THE HUMERAL HEAD AND EXPOSED THE PROXIMAL STEM, NOTING A DARK BUILD-UP COVERING THE HUMERUS. THE GLENOID IMPLANT WAS FOUND DISASSOCIATED, WITH THE POROUS POST REMAINING WELL-FIXED IN BONE AND LATER REMOVED. THERE WAS A LOOSENING OF GLENOID IMPLANT AT THE CEMENT TO IMPLANT INTERFACE. CEMENT WAS COMPETITOR. A METALLOSIS WAS SUSPECTED AS THE CAUSE OF THE DARK BUILD-UP. DOI: (B)(6) 2024, DOR: (B)(6) 2026, AFFECTED SIDE: UNKNOWN SHOULDER.

  Patient problems: Foreign Body Reaction

  MAUDE report 24471607 ↗
• InjuryNov 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO A REVERSE FROM ANATOMIC DUE TO CUFF FAILURE. THERE WAS NO IMPLANT FAILURE AND NO BROKEN PIECES. THERE WAS NO DELAY. NO OTHER INFORMATION KNOWN. DOI: (B)(6) 2022. DOR: (B)(6) 2025 . AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23555893 ↗
• InjuryMar 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A FAILED PRIMARY TOTAL SHOULDER DUET TO SOFT TISSUE AND MUSCLE DEFICIENCY AND WAS CONVERTED TO A REVERSE TOTAL SHOULDER. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 21683874 ↗
• InjuryOct 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO SHOULDER INFECTION. THE SURGEON WANTED TO REMOVE THE HUMERAL HEAD AND ADAPTER, SO HE COULD THOROUGHLY WASH THE SHOULDER OUT. ONCE THE SHOULDER WAS CLEANED, HE WANTED TO PLACE A NEW HUMERAL HEAD AND ADAPTER BACK IN, AND CLOSE THE SHOULDER. NO ADVERSE EVENTS TOOK PLACE. NO SURGICAL DELAYS OCCURRED. JUST A WASHOUT AND HEAD EXCHANGE WAS PERFORMED. DOI: (B)(6) 2023 DOR: (B)(6) 2023 AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 17903867 ↗
• InjuryOct 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO STIFFNESS AND PAIN. THERE WAS NO SURGICAL DELAY REPORTED. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 17850270 ↗