INHANCE 5500-40-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295546542), received between Jan 30, 2024 and Jul 10, 2026 — classified as 10 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJul 10, 2026Adverse Event Without Identified Device or Use Problem

  UPDATED EVENT DESCRIPTION-SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR MECHANICAL LOOSENING OF STEMLESS COMPONENT. DEVICE AND PROCEDURE (RELATEDNESS). DEVICE RELATED: CAUSAL RELATIONSHIP. PROCEDURE RELATED: CAUSAL RELATIONSHIP. DATE OF EVENT: 16 JUN 2026. DATE OF IMPLANT: (B)(6) 2026. DATE OF REVISION: (B)(6) 2026. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: SURGICAL INTERVENTION FOR THE STUDY SHOULDER (SINGLE-STAGE REVISION), COMPONENTS REMOVED (HUMERAL STEMLESS IMPLANT, REVERSE HUMERAL SHELL, REVERSE LINER). DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 520000040. LOT NUMBER: 664288-1. COMPONENT TYPE: HUMERAL. DESCRIPTION: INHANCE SHOULDER SYSTEM STEMLESS LARGE DIAMETER 40MM CEMENTLESS. CATALOG NUMBER: 550000400. LOT NUMBER: 664547. COMPONENT TYPE: SHELL. DESCRIPTION: INHANCE REVERSE HUMERAL. SHELL L 40+0. CATALOG NUMBER: 550040100. LOT NUMBER: MI124738. COMPONENT TYPE: LINER. DESCRIPTION: INHANCE SHOULDER SYSTEM REVERSE LINER RETENTIVE X-LINKED VITAMIN E PE Ø40+0MM.

  Patient problems: Swelling/ Edema

  MAUDE report 25782698 ↗
• 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 24365277 ↗
• InjurySep 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INSTABILITY. DOI: (B)(6), 2025 DOR: (B)(6) 2025 AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 23026591 ↗
• InjuryJul 18, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION AND NEEDED LATERALIZED GLENOSPHERE, THICKER POLY. AFFECTED SIDE: UNKNOWN SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 22541834 ↗
• InjuryJul 16, 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 INFECTION. ALL COMPONENTS WERE TAKEN OUT. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 22522962 ↗
• InjuryJul 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY DUE TO PAIN.

  Patient problems: Pain

  MAUDE report 22520857 ↗
• InjuryMar 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAINFUL SHOULDER. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Pain

  MAUDE report 21657365 ↗
• InjuryNov 13, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT RIGHT SHOULDER WAS REVISED ON (B)(6) 2024 DUE TO CONTINUING POST-OP DISLOCATION. SURGICAL DELAY UNKNOWN. DATE OF IMPLANT (B)(6) 2024

  Patient problems: Joint Dislocation

  MAUDE report 20675694 ↗
• 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 20480207 ↗
• InjuryOct 8, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  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: Joint Dislocation

  MAUDE report 20398267 ↗
• 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 18606199 ↗