INHANCE 5200-51-180Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295538400), received between Feb 3, 2023 and Apr 27, 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. 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• 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 25000046 ↗
• 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 24768091 ↗
• InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INFECTED AN SHOULDER. REVISION WAS PERFORMED. IT WAS REPORTED THAT IT WAS NOT RELATED TO ANY DEPUY PRODUCT. AFFECTED SIDE: UNKNOWN SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 23371641 ↗
• 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 22731895 ↗
• InjuryJan 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD THEIR SHOULDER DONE ON (B)(6) 2024. UNFORTUNATELY, THE LESSER TUBEROSITY REPAIR FROM THE ANATOMIC SURGERY FAILED. DOCTOR FELT THE PATIENT WOULD BENEFIT FROM CONVERTING THEIR SHOULDER TO A REVERSE. THE GLENOID IMPLANT WAS REMOVED AND PREPPED FOR A REVERSE BASEPLATE AND GLENOSPHERE. A SHELL AND POLY WAS TRAILED ON THE EXISTING STEM AND THE SHOULDER WAS REDUCED. REAL IMPLANTS WERE OPENED AND IMPLANTED. STABILITY WAS CONFIRMED AND THE CLOSING PROCESS BEGAN. NO DELAYS OR ADVERSE EVENTS TOOK PLACE. DOI: ON (B)(6) 2024, DOR: ON (B)(6) 2025, AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 21251609 ↗
• InjuryMay 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED WITH SUBSCAP FAILURE DUE TO PATIENT NON COMPLIANCE. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16942111 ↗
• InjuryFeb 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S SHOULDER WAS NOT STABLE, NEEDED TO GO TO A REVERSE. DOI: (B)(6) 2019. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 16297225 ↗