INHANCE 5120-00-110Recalls & reported problems

Summary

The FDA's MAUDE database contains 75 adverse event reports that list this exact device (DI 10603295538189), received between Oct 25, 2022 and Sep 17, 2026 — classified as 73 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (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 25 most recent of 75 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 50805925 ↗
• 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 50753833 ↗
• InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem

  Patient had an anatomic total shoulder done in July 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 50730937 ↗
• 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 arthroplasty.DOI: (b)(4) 2025.DOR: (b)(6) 2026.Affected side: Left shoulder.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 50696068 ↗
• InjuryJul 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FROM INHANCE TOTAL TO INHANCE REVERSE DUE TO ROTATOR CUFF FAILURE. DOI: (B)(6) 2024. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 25692903 ↗
• InjuryJun 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT HEMI REVISED DUE TO FAILED ROTATOR CUFF/CHRONIC SUBLUXATION. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 25667866 ↗
• InjuryJun 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO PAIN. AFFECTED SIDE-RIGHT SHOULDER.

  Patient problems: Pain

  MAUDE report 25390770 ↗
• InjuryMay 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED TO A REVERSE DUE TO INSTABILITY. DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 25256795 ↗
• InjuryApr 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE INITIAL SURGERY THE PATIENT UNFORTUNATELY SUFFERED FROM ROTATOR CUFF FAILURE AND THEIR SHOULDER NEEDED TO BE CONVERTED. THE HUMERAL HEAD, ANATOMIC ADAPTER, AND HYBRID GLENOID WERE REMOVED. GLENOID WAS THEN PREPPED FOR A REVERSE BASEPLATE AND GLENOSPHERE. HUMERAL SIDE WAS THEN CONVERTED TO A HUMERAL SHELL AND POLY. STABILITY OF THE SHOULDER WAS CONFIRMED WITH TRIAL COMPONENTS BEFORE DEFINITIVE IMPLANTS WERE OPENED AND IMPLANTED. NO DELAYS OR ADVERSE EVENTS TOOK PLACE. ACTIVITY LEVEL - YES. AFFECTED SIDE: RIGHT.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24999980 ↗
• InjuryApr 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FAILED ROTATOR CUFF. CONVERTED TO REVERSE. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24884883 ↗
• InjuryApr 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT FELL AND TORE ROTATOR CUFF. CONVERTED TO REVERSE TOTAL SHOULDER. NO ADVERSE PATIENT OUTCOMES OR TIME SPENT. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24818723 ↗
• 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 24802353 ↗
• InjuryApr 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN ANATOMIC SHOULDER ARTHROPLASTY DONE ON JULY 1, 2025. PATIENT STATED THEY WERE DOING WELL FOR 4-5 MONTHS UNTIL THEY SUDDENLY COULDN¿T LIFT THEIR ARM DUE TO A SUBSCAP TEAR. TODAY, THE PATIENT WAS CONVERTED FROM AN ANATOMIC SHOULDER TO A REVERSE SHOULDER. THE ANATOMIC HUMERAL HEAD WAS REMOVED ALONG WITH THE OFFSET TAPER ADAPTER, THE HYBRID GLENOID WAS REMOVED AND REPLACED WITH A REVERSE BASEPLATE. STEMLESS COMPONENT WAS REMOVED AND REPLACED WITH A STANDARD STEM. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24790328 ↗
• 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: (B)(6), 2022. DOR: (B)(6), 2026. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24789186 ↗
• 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: ON (B)(6) 2025, DOR: ON (B)(6) 2026, AFFECTED SIDE: LEFT.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24769600 ↗
• InjuryApr 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CONVERSION FROM ANATOMIC TSA TO REVERSE TSA DUE TO FAILED LESSER TUBEROSITY OSTEOTOMY (LTO). ROTATOR CUFF WAS COMPROMISED. DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24768398 ↗
• InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT TORE THEIR ROTATOR CUFF. NEEDED TO SWITCH TO A REVERSE. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24745219 ↗
• 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 24414209 ↗
• InjuryFeb 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT¿S ROTATOR CUFF FAILED AND NEEDED TO BE CONVERTED TO REVERSE. THE CONVERTIBLE POLY WAS REMOVED ALONG WITH THE HUMERAL HEAD AND OFFSET TAPER ADAPTER. A GLENOSPHERE WAS OPENED AND IMPLANTED. TRIAL SHELL WAS USED ON THE EXISTING STEMMED IMPLANT AND THE SHOULDER WAS REDUCED. STABILITY WAS SATISFACTORY, SO THE REAL SHELL AND POLY WERE OPENED AND IMPLANTED. NO DELAYS OR ADVERSE EVENTS TOOK PLACE. ACTIVITY LEVEL - YES. DOI: (B)(6) 2025, DOR: UNKNOWN, AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24270326 ↗
• InjuryJan 27, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO LOST ROTATOR CUFF FUNCTION. ENHANCE ANATOMIC WAS CONVERTED TO REVERSE. DOI: (B)(6) 2025, DOR: (B)(6) 2026, AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24189732 ↗
• 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 23922204 ↗
• InjuryDec 22, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVED: CAN YOU PLEASE CONFIRM IF THIS IS LEFT OR RIDE SIDE? IT WAS THE PATIENT¿S RIGHT SHOULDER, AND THE HUMERAL HEAD AND TAPER ADAPTER (AS A CONSTRUCT) WERE DISASSOCIATED FROM THE STEMLESS IMPLANT. THE STEMLESS IMPLANT WAS WELL FIXED, SO THE SURGEON LEFT IT IN AND REPLACED THE HEAD AND ADAPTER WITH A NEW ONE.

  Patient problems: Insufficient Information

  MAUDE report 23865695 ↗
• 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 23864741 ↗
• InjuryDec 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON WAS DISSATISFIED WITH POST-OP IMAGING AND DECIDED TO PERFORM A REVISION PROCEDURE. THE EVENT DID NOT OCCUR DURING SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 23783516 ↗
• InjuryDec 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INHANCE ANATOMIC PROCEDURE IN (B)(6). UNFORTUNATELY, PATIENT'S SUBSCAP TENDON WENT ON TO FAILURE. PATIENT WAS REVISED TO A REVERSE INHANCE. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23782803 ↗