INHANCE 5200-00-032Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295538264), received between Jun 20, 2023 and Apr 7, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Migration” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 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 24802318 ↗
• 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 23783517 ↗
• InjuryOct 15, 2025Migration; Migration

  IT WAS REPORTED THAT THE PATIENT HAD INITIAL SURGERY DONE ON (B)(6) 2024. PATIENT WAS DEALING WITH INSTABILITY ISSUES WITH DISLOCATIONS. THE SURGEON FELT THE PATIENT'S HUMERAL COMPONENT WAS IN VARUS AND THAT COULD BE CONTRIBUTING TO INSTABILITY. THEY REMOVED THE HUMERAL COMPONENTS AND OPTED FOR A STANDARD-LENGTH STEM IN HOPES TO STRAIGHTEN OUT THE HUMERAL SIDE. THEY ALSO SWAPPED OUT THE OLD GLENOSPHERE FOR A NEW ONE. A TRIAL REDUCTION WAS PERFORMED WITH A +0 HUMERAL SHELL AND +4 RETENTIVE POLY. THE SURGEON FELT IT WAS MUCH MORE STABLE, SO THE REAL IMPLANTS WERE OPENED AND IMPLANTED. STABILITY WAS CONFIRMED AND THE CLOSING PROCESS BEGAN. NO DELAYS OR ADVERSE EVENTS TOOK PLACE. DOI: (B)(6) 2024, DOR: UNKNOWN, AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 23284997 ↗
• InjuryJun 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO DISLOCATION/INSTABILITY FOLLOWING TOTAL SHOULDER REPLACEMENT. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 17164823 ↗