INHANCE 5500-40-104Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295546498), received between Mar 20, 2024 and May 26, 2026 — classified as 6 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 26, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT PATIENT HAD 2ND REVISION FOR GLENOSPHERE DISASSOCIATION FROM THE BASEPLATE. LOCKING SCREW WAS STILL LOCKED INTO BASEPLATE AND INTACT. DOI- (B)(6) 2024. DOR- (B)(6) 2026. AFFECTED SIDE- RIGHT SHOULDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25276725 ↗
• InjuryApr 13, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT HAD A TOTAL SHOULDER DONE IN (B)(6) 2025, HAD SEVERAL DISLOCATIONS. DR WENT IN AND MADE A THICKER CONSTRUCT. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT SHOULDER

  Patient problems: Joint Dislocation

  MAUDE report 24861109 ↗
• MalfunctionNov 25, 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 GLENOSPHERE BEING DISLODGED FROM BASEPLATE. THE LOCKING SCREW WAS STILL SCREWED INTO BASEPLATE WITH NO DAMAGE TO ANY OF THE THREADS. IT WAS STATED THAT THE GLENOSPHERE WERE LOOSE. LOOSENING INTERFACE WAS MARKED AS NON-CEMENTED. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Insufficient Information

  MAUDE report 23644797 ↗
• 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 23393279 ↗
• InjuryJul 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS 3 WEEKS POST-OP FROM A REVERSE TOTAL SHOULDER ARTHROPLASTY. THE WOUND WAS OOZING AND LABS INDICATED THE PRESENCE OF INFECTION. THIS PROCEDURE WAS I&D WITH HARDWARE EXCHANGE. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Fluid Discharge; Unspecified Infection

  MAUDE report 22588606 ↗
• InjuryNov 21, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT AFTER THE PATIENT HAD THEIR ORIGINAL SHOULDER DONE, THE SHOULDER BECOME DISLOCATED. ACCORDING TO SURGICAL IMPLANT RECORDS, THE PATIENT WAS IMPLANTED WITH A 40+8 GLENOSPHERE, MEDIUM +8 SHELL, AND A 40 +4 RETENTIVE POLY. WITH THAT CONSTRUCT PRETTY MUCH MAXED OUT, THE SURGEON FELT THE PATIENT'S HUMERAL COMPONENTS WOULD NEED TO BE REVISED AS A WHOLE. THE HUMERAL STEM WAS REMOVED AND THE PATIENT WAS THEN PREPPED FOR A BIOMET HUMERAL COMPONENT. WITH THE BASEPLATE WELL FIXED, THE SURGEON OPTED TO LEAVE IT AND PLACE A 40+8 ECCENTRIC GLENOSPHERE. ONCE THE BIOMET PREP WAS COMPLETE, THE SHOULDER WAS REDUCED AND PUT THROUGH A FULL RANGE OF MOTION AND FOUND TO BE STABLE. DOI: (B)(6) 2023; DOR: (B)(6) 2024; AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 20751090 ↗
• InjuryOct 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT I&D WITH THE GLENOSPHERE, HUMERAL SHELL AND POLY EXCHANGE FOR CONFIRMED INFECTION. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 20409408 ↗
• InjuryMar 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT INITIAL SURGERY WAS DONE (B)(6) 2023 BY THE SURGEON AT HOSPITAL. PATIENT WAS THEN REVISED DUE TO INSTABILITY ON (B)(6) 2023. UNFORTUNATELY THE PATIENT CAME BACK AGAIN, BUT THIS TIME FOR INFECTION. ALL IMPLANTS WERE REMOVED AND THE SHOULDER WAS THOROUGHLY WASHED. THERE WAS NO SURGICAL DELAYS OR ADVERSE EVENTS TOOK PLACE. THE SHOULDER WAS CLOSED AFTER A THOROUGH WASHOUT. DOI: (B)(6) 2023; DOR: UNKNOWN; AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 18940785 ↗