INHANCE 5500-36-004Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10603295546795), received between Jun 22, 2023 and Mar 30, 2026 — classified as 22 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (7 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED INFECTION DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 24731695 ↗
• InjuryJan 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A REVERSED TOTAL SHOULDER REVISION OCCURRED DUE TO GLENOSPHERE AND LINER IMPINGEMENT. PATIENT WAS CONVERTED TO HEMI ARTHOPLASTY. DURING THE PROCEDURE THE HEAD TRIAL WAS DAMAGED WHERE THE ADAPTOR FOR HEAD AND TRIAL MEET. THE ATTACHMENT TABS BROKE OFF. THERE WAS NO HARM TO PATIENT AND NO SURGICAL DELAY. DOE: (B)(6) 2026. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 24188353 ↗
• InjuryDec 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. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 23803296 ↗
• InjuryDec 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR INSTABILITY. INCREASED GLENO AND ADDED RETENTIVE POLY. NO LOOSENING OR IMPLANT FAILURE. NO CASE DELAY. NO BROKEN PIECES. ALL PIECES WERE REMOVED. NO OTHER INFORMATION KNOWN. DOI (B)(6) 2025, DOR (B)(6) 2025, AFFECTED SIDE-RIGHT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 23761257 ↗
• InjuryDec 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. SURGEON DECIDED INTRAOP TO INCREASE GLENOSPHERE SIZE. THERE WAS NO COMPLAINT OR LOOSENING. NO DELAY. NO BROKEN PIECES, NOTHING LEFT BEHIND. NOT SURE OF ORIGINAL IMPLANTATION DATE. NO OTHER INFORMATION KNOWN. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 23744246 ↗
• InjuryNov 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE REVISION WAS FOR INSTABILITY. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 23658196 ↗
• 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 23295152 ↗
• InjuryJun 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE STEMLESS REVERSE SPUN OUT, THE SUPERIOR MEDIAL WALL OF THE HUMERUS WAS BLOWN OUT. THERE WAS LOOSENING OF STEMLESS COMPONENT. SURGEON STATE IT LOOKED TRAUMATIC BUT PATIENT REPORTED NO INCIDENT. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Bone Fracture(s)

  MAUDE report 22337111 ↗
• InjuryJun 23, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION AND THE SURGEON ELECTED TO OPEN AND TIGHTEN UP THE JOINT WITH A THICKER CONSTRUCT. DOI: (B)(6) 2024. DOR: (B)(6) 2025 AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 22311643 ↗
• InjuryJun 13, 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 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: Insufficient Information

  MAUDE report 22206857 ↗
• 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 22206854 ↗
• InjuryMay 30, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT FELT A POP WHILE WORKING IN HIS GARAGE. A COUPLE DISLOCATIONS SINCE THEN. ALL COMPONENTS WERE WELL FIXED. NO OBVIOUS REASON FOR DISLOCATIONS. REMOVED THE 0 SHELL AND +4 LINER. INCREASED TO A +8 SHELL AND +0 RETENTIVE LINER. PATIENT SEEMS STABLE. NO OTHER INFORMATION. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 22113379 ↗
• InjuryMay 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION AND WASH OUT. SWAPPED OUT IMPLANTS THAT WERE EASILY REMOVED (GLENOSPHERE, POLY, SHELL, SCREWS). DID NOT TAKE OUT STEM OR R SPEED AS WAS VERY INGROWN. NO IMPLANT FAILURE. UNSURE OF WHERE INFECTION CAME FROM. NO BROKEN IMPLANTS. NO PIECES LEFT BEHIND. NO CASE DELAY. NO OTHER INFORMATION KNOWN. DOI: ON (B)(6) 2025, DOR: ON (B)(6) 2025, AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 22099248 ↗
• InjuryMay 6, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED FOR DISLOCATION. THE STEM WAS SUBSIDED AS WELL. THE SURGICAL DELAY IS UNKNOWN. DOI: UNKNOWN , DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 21971133 ↗
• InjuryOct 25, 2024Adverse 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 POSSIBLE INFECTION. MODULAR IMPLANTS EXCHANGED. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN. DOE: (B)(6) 2024. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 20532977 ↗
• InjuryOct 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT WAS REVISED ON (B)(6) 2024 DUE TO PROBABLE INFECTION. ORIGINAL IMPLANT DATE WAS (B)(6) 2023.

  Patient problems: Unspecified Infection

  MAUDE report 20500823 ↗
• InjurySep 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON REVISED THE INHANCE POLY CUP AND SHELL FOR INSTABILITY. DOI: UNKNOWN, DOR: (B)(6) 2024, AFFECTED SIDE : RIGHT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 20226094 ↗
• InjuryMay 9, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  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 Dislocation; Joint Laxity

  MAUDE report 19277943 ↗
• InjuryMar 15, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION. STEM WAS LOOSE. DOI: (B)(6), 2024. DOR:(B)(6) 2024. AFFECTED SIDE: UNKNOWN SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 18913377 ↗
• InjuryJan 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD IRRIGATION AND DEBRIDEMENT DUE TO INFECTION WITH AN EXCHANGE OF ALL MODULAR PIECES. DOI: (B)(6) 2023; DOR: (B)(6) 2024; AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 18558374 ↗
• MalfunctionJan 18, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT POLYS WOULD NOT FIT. THE PRODUCT WERE DEFECTIVE. DOE: (B)(6) 2024 AFFECTED SIDE: UNKNOWN SHOULDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18534888 ↗
• InjuryDec 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S SHOULDER WAS ORIGINALLY DONE ON (B)(6) 2022 AT A HOSPITAL. PATIENT SHOULDER BECAME INFECTED SO THE SURGEON FELT THEY WOULD BENEFIT FROM A THOROUGH WASHOUT OF THEIR SHOULDER WITH IMPLANT EXCHANGE. THE GLENOSPHERE, NUMERAL SHELL, AND POLY WERE REMOVED AND THE SHOULDER WAS THOROUGHLY CLEANED. A NEW 36 GLENOSPHERE WAS IMPLANTED. A TRIAL REDUCTION WAS PERFORMED WITH A NEW SHELL AND POLY. THE SHOULDER WAS FOUND TO BE STABLE, SO THE REAL SHELL AND POLY WERE OPENED AND IMPLANTED. STABILITY OF THE SHOULDER WAS CONFIRMED AND THE CLOSING PROCESS BEGAN. NO ADVERSE EVENTS TOOK PLACE. DOI: (B)(6); DOR: NOV 27, 2023; AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 18274489 ↗
• InjuryJun 22, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 17180921 ↗