INHANCE 5100-29-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295538134), received between Jan 5, 2022 and Sep 14, 2026 — classified as 10 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that conversion of Anatomic shoulder to reverse due to rotator cuff arthropathy.Affected side: Left shoulder.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 50753716 ↗
• InjuryApr 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD AN ANATOMIC SHOULDER ARTHROPLASTY DONE (B)(6) 2022. ON (B)(6) 2026, PATIENT WAS REVISED TO A REVERSE SHOULDER ARTHROPLASTY, DUE TO A SUBSCAP TEAR. THE HUMERAL HEAD WAS REMOVED ALONG WITH THE OFFSET TAPER ADAPTER, A LARGE ANATOMIC GLENOID WAS REMOVED AND REPLACED WITH A REVERSE BASEPLATE. THE MEDIUM SHORT STEM WAS RETAINED AND CONVERTED TO REVERSE WITH A REVERSE SHELL. DOI: APRIL 26, 2022. DOR: MARCH 17, 2026. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24789188 ↗
• InjuryDec 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT TORE ROTATOR CUFF, SURGEON CONVERTED THEM TO A REVERSE. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23922379 ↗
• InjuryDec 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT TORE SUBSCAP REQUIRING A CONVERSION TO A REVERSE TOTAL SHOULDER. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23864619 ↗
• InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT TORE THE ROTATOR CUFF AND REVERSE TSA WAS NEEDED. SURGEON CONVERTED EXISTING INHANCE STEM TO A REVERSE. DOI: (B)(6) 2022. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23692290 ↗
• InjuryOct 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED FROM ANATOMIC TO REVERSE FAILED ROTATOR CUFF. IT WAS PERFORMED BY A DIFFERENT SURGEON AT A DIFFERENT HOSPITAL. THERE WAS NO IMPLANT FAILURE. NO CASE DELAY. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23356274 ↗
• InjuryAug 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS CONVERTING TO REVERSE DUE TO ROTATOR CUFF TEAR. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 22731915 ↗
• InjuryJan 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED OF A PATIENT SHOULDER CONVERSION TO REVERSE A FAILED SUBS-CAP. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 21267762 ↗
• InjuryMar 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO PROGRESSIVE PAIN AND LOSS OF FUNCTION LEFT ARM. DOI: (B)(6) 2022; DOR: (B)(6) 2024; AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 18943080 ↗
• InjuryJul 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH AN ANATOMICAL SHOULDER CONSTRUCT. THE PATIENT SUFFERED A TEAR OF THE SUBSCAP AND SURGEON FELT THE PATIENT WOULD BENEFIT FROM A CONVERSION TO A REVERSE TOTAL SHOULDER. THE NUMERAL HEAD, OFFSET ADAPTER, AND GLENOID WERE REMOVED AND THE SHOULDER WAS PREPPED FOR A REVERSE. SHOULDER WAS FOUND TO BE STABLE AND FINAL IMPLANTS WERE ALL INSERTED. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE : RIGHT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17361904 ↗
• MalfunctionJan 5, 2022Fracture; Improper or Incorrect Procedure or Method; Fracture; Improper or Incorrect Procedure or Method

  ONE TAB ON THE GLENOID INSERTER TIP, BROKE DURING IMPACTION. NO ADVERSE AFFECTS ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13172648 ↗