INHANCE 5500-01-290Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295546627), received between Mar 22, 2023 and Apr 22, 2026 — classified as 8 injuries, 2 malfunctions.

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

• InjuryApr 22, 2026Device Dislodged or Dislocated; No Apparent Adverse Event

  IT WAS REPORTED THAT PATIENT HAD ORIGINAL SURGERY PERFORMED AS A REVERSE TOTAL SHOULDER ON (B)(6) 2024. PATIENT THEN HAD GLENOSPHERE FAIL AND SEPARATE FROM THE BASEPLATE, LEADING TO THE SECOND SURGERY PERFORMED ON (B)(6) 2025. FOR THAT REVISION, SURGEON ONLY REPLACED THE GLENOSPHERE AND THE HUMERAL REVERSE LINER. THE PATIENT THEN HAD THEIR GLENOSPHERE FAIL AGAIN AND SEPARATE FROM THE BASEPLATE. SURGEON REVISED AGAIN FOR A THIRD CASE ON (B)(6) 2026. SURGEON TOOK EVERYTHING OUT OTHER THAN THE HUMERAL STEM AND REPLACED WITH DEPUY PRODUCTS. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT SHOULDER. THIS REPORT CAPTURES THE REVISION SURGERY PERFORMED ON (B)(6) 2025, WHILE RELATED COMPLAINT (B)(4) CAPTURES THE SECOND REVISION SURGERY PERFORMED ON (B)(6) 2026.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24955953 ↗
• InjuryApr 14, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT GLENOSPHERE 40+8 FAILED AND SEPARATED FROM THE BASEPLATE, RESULTING IN THE NEED FOR REVISION OF A REVERSE TOTAL SHOULDER ARTHROPLASTY. THE REPORTED FAILURE INVOLVED LOOSENING OF THE GLENOSPHERE AT THE NON-CEMENTED INTERFACE, AND THE DEVICE WAS EXPLANTED AND IS AVAILABLE FOR RETURN. THE PATIENT REQUIRED CORRECTIVE INVASIVE PROCEDURES, INCLUDING MULTIPLE REVISIONS, BUT THERE WERE NO ADVERSE CONSEQUENCES REPORTED AS A RESULT OF THESE EVENTS. THE COMPLAINT ALSO INVOLVES MODULAR UNITI BASEPLATE L 29, WHICH WAS PART OF THE REVISED CONSTRUCT. OTHER ASSOCIATED PRODUCTS, SUCH AS REVERSE LINER 40+0 R, CENTRAL SCREW 6.0 X 25, LOCKING SCREW 40, LOCKING SCREW 25, LOCKING SCREW 20, AND REVERSE HUMERAL SHELL XL 44+0, WERE ALSO EXPLANTED, BUT NO PATIENT CONSEQUENCES WERE REPORTED FOR THESE COMPONENTS. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Insufficient Information

  MAUDE report 24872929 ↗
• InjuryApr 8, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISASSOCIATION OF THE GLENOSPHERE FROM THE BASEPLATE BASE PLATE WAS NOT EXPLANTED. LOOSENING INTERFACE WAS MARKED AS BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2024. DOR: UNKNOWN. AFFECTED SIDE: UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 24819001 ↗
• InjurySep 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT GROSSLY INFECTED HAD TO REMOVE IMPLANTS. DOI: UNKNOWN. DOR:(B)(6), 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 22978086 ↗
• InjuryJul 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 22644722 ↗
• 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 22522971 ↗
• InjuryJan 9, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD THEIR ORIGINAL SURGERY (B)(6) 2024. WHILE AT THE GYM THROWING AROUND A 15LB WEIGHT, PATIENT FELT A POP IN HIS SHOULDER. THE SURGEON BROUGHT PATIENT IN ON (B)(6) 2024 TO REVISE HIS LEFT SHOULDER BECAUSE THE GLENOSPHERE HAD DISASSOCIATED FROM THE BASEPLATE. AFTER REMOVING THIS IMPLANT, SURGEON NOTICED THAT THE SAFETY SCREW HOUSED WITHIN THE GLENOSPHERE STILL SEEMED TO BE SET INTO THE GLENOSPHERE AND THE THREADS NEVER ENGAGED THE BASEPLATE. SURGEON REMOVED THIS IMPLANT, AND PLACED A NEW ONE WITH NO ISSUE. THE TAPER ENGAGED, AND THE SAFETY SCREW WAS SCREWED INTO THE BASEPLATE WITH NO INCIDENT. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2024, AFFECTED SIDE: UNKNOWN SHOULDER.

  Patient problems: Insufficient Information

  MAUDE report 21115435 ↗
• MalfunctionOct 14, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING SURGERY ON AN UNKNOWN DATE, THE LOCKING SCREW WENT STRAIGHT THROUGH THE BASEPLATE HOLE. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20439380 ↗
• InjuryMar 23, 2024Migration; Migration

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: Bone Fracture(s)

  MAUDE report 18966113 ↗
• MalfunctionMar 22, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT WHEN PLACING LOCKING SCREWS INTO THE BASEPLATE, IT WAS NOTICED BY THE SURGEON THAT THE SCREW PASSED THROUGH THE BASEPLATE SCREW HOLE ENTIRELY WITHOUT ENGAGING AND LOCKING INTO THE BASEPLATE. HE WAS ABLE TO BACK THE SCREW OUT AND RE-ENGAGE IT TO THE PLATE. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Insufficient Information

  MAUDE report 16590777 ↗