INHANCE 5200-46-160Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295538363), received between Feb 15, 2023 and Apr 7, 2026 — classified as 10 injuries, 2 malfunctions.

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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT CONVERSION TO REVERSE DUE TO SUBSCAP FAILURE. AFFECTED SIDE: RIGHT.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24802417 ↗
• InjuryApr 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD AN ANATOMIC SHOULDER ARTHROPLASTY DONE ON (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: (B)(6) 2022. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24789183 ↗
• InjuryFeb 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT SUFFERED A ROTATOR CUFF FAILURE. PATIENT NEEDED TO HAVE THEIR SHOULDER CONVERTED TO A REVERSE. ANATOMIC IMPLANTS WERE REMOVED AND SHOULDER WAS PREPARED AND IMPLANTED WITH REVERSE COMPONENTS. SHOULDER STABILITY WAS CONFIRMED. THERE WAS NO DELAYS OR ADVERSE EVENTS TOOK PLACE. DOI: (B)(6) 2023. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24414234 ↗
• MalfunctionDec 23, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO ANATOMIC HEAD DISASSOCIATED FROM STEMLESS COMPONENT. NO ADDITIONAL INFORMATION. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT SHOULDER. (B)(4) & (B)(4) ARE RELATED. (B)(4) IS CREATED FOR RIGHT SHOULDER, (B)(4) IS CREATED FOR LEFT SHOULDER.

  Patient problems: Insufficient Information

  MAUDE report 23877623 ↗
• 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 23864697 ↗
• InjuryDec 10, 2025Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT PATIENT FELL AND TORE RC. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN SHOULDER.

  Patient problems: Fall; Unspecified Tissue Injury

  MAUDE report 23772104 ↗
• InjuryDec 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO CUFF TEAR. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23707240 ↗
• 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 23692231 ↗
• InjurySep 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO CONVERSION TO REVERSE SHOULDER BECAUSE OF CUFF TEAR. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 22938375 ↗
• InjurySep 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SURGEON REPLACED THIS PATIENTS SHOULDER IN MAY THIS YEAR WHERE HE RECEIVED A INHANCE ANATOMIC STEMLESS CONSTRUCT. THIS PATIENT UNFORTUNATELY TORE HIS ROTATOR CUFF IN JUNE AND LOST FUNCTION. IT WAS DETERMINED THAT HIS ANATOMIC CONSTRUCT WOULD BE CONVERTED TO A REVERSE CONSTRUCT TO REGAIN FUNCTION AND MOTION. THERE WAS NO SURGICAL DELAY, ADVERSE EVENTS, OR ANY IMPLANT FAILURE TO REPORT. THE STEMLESS COMPONENT WAS RETAINED, THE GLENOID, HUMERAL HEAD, AND TAPER ADAPTOR WERE EXPLANTED AND REVERSE COMPONENTS WERE IMPLANTED. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Loss of Range of Motion; Unspecified Tissue Injury

  MAUDE report 20136647 ↗
• MalfunctionJan 29, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE 46X16 HAS A BROKEN TAB AND THE TRIAL OFFSET ADAPTER WILL NOT STAY IN THE HEAD. 32+0 POLY TRIAL WILL NOT STAY IN THE +8 SPACER.

  Patient problems: Insufficient Information

  MAUDE report 18594972 ↗
• InjuryFeb 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO SUBSCAPULARIS FAILURE. DOI- (B)(6) 2022. DOR- (B)(6) 2023. AFFECTED SIDE- LEFT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16378279 ↗