INHANCE 5500-00-280Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295547037), received between Jul 18, 2024 and Jun 13, 2025 — classified as 5 injuries.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJun 13, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION OF SHOULDER. GLENOSPHERE, POLY AND SHELL WERE EXCHANGED ALL OTHER COMPONENTS WERE STABLE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED. DOI: (B)(6) 2025. DIOR: (B)(6) 2025. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 22206856 ↗
• InjuryMar 4, 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 INSTABILITY FOLLOWING RTSA FOR FRACTURE. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 21513457 ↗
• InjuryFeb 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 PERI PROSTHETIC FRACTURE OF THE HUMERUS, DR. REMOVED THE STANDARD-LENGTH STEM AND REPLACED WITH A LONG STEM WITH CABLES. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Bone Fracture(s)

  MAUDE report 21291786 ↗
• InjuryDec 4, 2024Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN OLD FRACTURE BEFORE HER FIRST SURGERY AND MADE FOR DIFFICULT HUMERAL PREP DURING APEX PROCEDURE. THE SURGEON STATED THE PATIENT FELL AWHILE BACK AND DISLOCATED HER HIP AND SHOULDER DURING THE FALL. THE SURGEON TRIED TO RELOCATE THE SHOULDER CLOSED BUT WAS UNSUCCESSFUL. THE SURGEON ELECTED TO OPEN AND EVALUATE THE SHOULDER. UPON OPENING THE SHOULDER, THE HUMERAL IMPLANT WAS LOOSE BECAUSE OF BONE LOSS. THE HUMERAL COMPONENT WAS LOOSE WITH NON-CEMENTED INTERFACE. THE SURGEON REPLACED WITH A LONGER STEM AND HYBRID FIXATION. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Inadequate Osseointegration; Unspecified Tissue Injury

  MAUDE report 20843006 ↗
• InjuryJul 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS NO SURGICAL DELAY REPORTED.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 19772742 ↗