INHANCE 5500-00-448Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295546702), received between Jan 30, 2024 and Apr 20, 2026 — classified as 4 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. 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.

• InjuryApr 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR INSTABILITY. DOI: UNKNOWN, DOR: (B)(6) 2026, AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 24924609 ↗
• InjuryMar 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD INJURED DURING PHYSICAL THERAPY. NO ADDITIONAL INFORMATION WAS GIVEN.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24665112 ↗
• MalfunctionFeb 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT INITIAL IMPLANTATION ON (B)(6) 2024. ON (B)(6) 2025 THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO DISSOCIATION OF THE GLENOSPHERE AND THE CENTRAL SCREW, PERIPHERAL SCREWS, HUMERAL TRAY AND LINER WERE REPLACED. ON (B)(6) 2025, THE PATIENT UNDERWENT ANOTHER REVISION PROCEDURE DUE TO DISSOCIATION OF THE GLENOSPHERE. THE GLENOSPHERE DISASSOCIATED FROM THE GLENOID BASEPLATE AND CENTRAL SCREW POST WITH THE SCREW POST REMAINING IN THE BASEPLATE. THE BASEPLATE WAS REPLACED IN THE GLENOSPHERE AND THE TRAY AND LINER WERE USED TO CREATE THE APPROPRIATE TENSION OF THE SHOULDER. DOI- (B)(6) 2025. DOR- (B)(6) 2025. AFFECTED SIDE- LEFT SHOULDER.

  Patient problems: Insufficient Information

  MAUDE report 24365207 ↗
• InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS REVISION DUE TO INSTABILITY.

  Patient problems: Joint Laxity

  MAUDE report 24304301 ↗
• InjuryJan 30, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT HAD INITIAL SURGERY DONE BY THE SURGEON AT THE HOSPITAL ON (B)(6) 2023. PATIENT WAS IMPLANTED WITH DEPUY HUMERAL COMPONENTS, AND BIOMET AUGMENTED GLENOSPHERE. THE GLENOSPHERE BECAME LOSE AND CAME COMPLETELY DISLODGED FROM THE GLENOID. SURGEON WANTED TO CONVERT THE SHOULDER TO A HEMI AND FELT THE HUMERAL SIDE WAS LOSE, SO SURGEON COMPLETELY REMOVED THE DEPUY HUMERAL SIDE AND ENDED UP IMPLANTING A ZIMMER BIOMET HEMI SHOULDER IMPLANT. NO ADVERSE EVENTS TOOK PLACE. DOI: (B)(6) 2023 DOR: (B)(6) 2024 AFFECTED SIDE: LEFT SHOULDER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18606195 ↗