INHANCE 5200-48-170Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295538387), received between Jul 20, 2023 and Dec 30, 2025 — classified as 10 injuries, 1 malfunction.

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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• 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 23922284 ↗
• InjuryOct 27, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT SHOULDER DISLOCATED AFTER REPLACEMENT. CONVERTED TO A REVERSE. AFFECTED SIDE- LEFT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 23393018 ↗
• 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 23356276 ↗
• InjuryJun 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN ANATOMIC TOTAL SHOULDER, HER ROTATOR CUFF HAD WORN OUT POSTOPERATIVELY. SURGEON CONVERTED PATIENT TO A REVERSE. AFFECTED SIDE: RIGHT SHOULDER. .

  Patient problems: Unspecified Tissue Injury

  MAUDE report 22302562 ↗
• InjuryMay 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT TORE ROTATOR CUFF AND SURGEON CONVERTED TO REVERSE. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 21988026 ↗
• InjuryJan 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: A. WAS/WERE THERE ANY ADVERSE CONSEQUENCE/S THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? NO. B. WAS THERE ANY SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? NO.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 21287346 ↗
• 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 21267745 ↗
• InjuryOct 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT TORE SUBSCAP AND ROTATOR CUFF. DOI- UNKNOWN. DOR- (B)(6) 2024. AFFECTED SIDE- RIGHT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 20368851 ↗
• MalfunctionMay 2, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE OFFSET TAPER ADAPTER WOULD NOT ENGAGE PROPERLY WITH THE HUMERAL HEAD WHEN IMPACTED TO FACE THE C (CENTERED) SETTING. DOE: (B)(6) 2024, AFFECTED SIDE: UNKNOWN SHOULDER SIDE.

  Patient problems: Insufficient Information

  MAUDE report 19228253 ↗
• 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 18943091 ↗
• 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: ON (B)(6) 2022, DOR: ON (B)(6) 2023, AFFECTED SIDE : RIGHT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17361911 ↗