INHANCE 5500-00-440Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295547020), received between May 9, 2024 and Jun 12, 2026 — classified as 10 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).

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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJun 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT UPON THE PATIENT LEAVING THE OPERATING ROOM, A POST-OPERATIVE X-RAY REVEALED THE HUMERAL STEM WAS POSITIONED IN VARUS AND HAD PERFORATED THE LATERAL HUMERUS. DOE: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Bone Fracture(s)

  MAUDE report 25488579 ↗
• InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DOCTOR PERFORMED IRRIGATION AND DEBRIDEMENT WITH MODULAR COMPONENT EXCHANGE DUE TO INFECTION. DOI: (B)(6) 2026. DOR:(B)(6) 2026. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 24675809 ↗
• InjuryFeb 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO LACK OF MOTION, WHICH INCLUDED SCAR EXCISION AND EXCHANGE OF THE GLENOSPHERE AND LINER. ALL COMPONENTS WERE NOTED TO BE WELL FIXED AT THE TIME OF REVISION. DOI: (B)(6) 2023, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Loss of Range of Motion; Scar Tissue

  MAUDE report 24251684 ↗
• InjuryOct 27, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE POLY WAS DISASSOCIATED FROM SHELL.

  Patient problems: Unspecified Musculoskeletal problem

  MAUDE report 23393157 ↗
• InjuryOct 15, 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. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 23295093 ↗
• InjurySep 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD NOTED SOME INSTABILITY. TRIALED A LARGER GLENOSPHERE, TRIALED A LARGER LINER, THEN TRIALED A LARGER SHELL. AFTER RUNNING IT THRU A RANGE OF MOTION, SURGEON NOTICED THAT STEM SEEMED TO BE SLIGHTLY LESS RETROVERTED TO HIS LIKING, DECIDED TO PULL AND REDO STEM AND UTILIZE A LONG STEM AND UPSIZE TO A LARGER GLENOSHPHERE, STICK WITH A ZERO SHELL AND UTILIZE A RETENTIVE POLY.

  Patient problems: Joint Laxity

  MAUDE report 22976367 ↗
• InjuryNov 5, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENTS RIGHT SHOULDER WAS REVISED ON (B)(6) 2024 DUE TO DISLOCATION. SURGICAL DELAY UNKNOWN. DATE OF IMPLANT WAS ON (B)(6) 2024.

  Patient problems: Joint Dislocation

  MAUDE report 20609007 ↗
• InjuryOct 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD INITIAL SURGERY AT A HOSPITAL ON (B)(6) 2023. PATIENT SHOULDER WAS INFECTED, SO DOCTOR FELT THEY WOULD BENEFIT FROM A WASHOUT OF THEIR SHOULDER AND AN EXCHANGE OF THE HUMERAL SHELL, POLY, AND GLENOSPHERE. THOSE IMPLANTS WERE REMOVED, THE SHOULDER WAS THOROUGHLY WASHED OUT, AND NEW IMPLANTS WERE INSERTED. STABILITY OF THE SHOULDER WAS CONFIRMED AND THE CLOSING PROCESS BEGAN. THERE WERE NO ADVERSE EVENTS OR DELAYS THAT TOOK PLACE. ACTIVITY LEVEL: YES. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 20480265 ↗
• InjuryOct 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CLAIMS THAT THEY DISLOCATED THEIR SHOULDER BY SWEEPING AND HAD SEVERAL PREVIOUS INSTANCES OF WHAT FELT LIKE DISLOCATION PRIOR TO THE COMPLETE DISLOCATION. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Insufficient Information

  MAUDE report 20398263 ↗
• InjuryMay 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: A. WAS THERE ANY PATIENT HARM RELATED TO THE EVENT ? B. IS THERE ANY ALLEGATION PRESENT AGAINST LINER? NO ON BOTH.

  Patient problems: Joint Laxity

  MAUDE report 19277955 ↗