INHANCE 5503-10-030Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295546597), received between May 27, 2025 and Sep 14, 2026 — classified as 6 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that all Inhance reverse implants were explanted due to infection.DOI: (b)(6) 2026.DOR: (b)(6) 2026.

  Patient problems: Unspecified Infection

  MAUDE report 50751496 ↗
• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that all Inhance reverse implants were explanted due to infection.DOI:(b)(6) 2026,DOR: (b)(6) 2026.

  Patient problems: Unspecified Infection

  MAUDE report 50751343 ↗
• InjuryJun 9, 2026Fracture

  IT WAS REPORTED THAT THE SHOULDER WAS REVISED BECAUSE OF BROKEN PERIPHERAL AND CENTER SCREW. IMPLANTS WERE REMOVED AND REPLACED. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 25446588 ↗
• InjuryMay 28, 2026Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6) STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR POOR ACTIVE MOTION, POSSIBLE AXILLARY NERVE INJURY DEVICE AND PROCEDURE (RELATEDNESS) DEVICE RELATED: NOT RELATED PROCEDURE RELATED: POSSIBLE DATE OF EVENT: 4 FEB 2026 DATE OF IMPLANT: (B)(6) 2026 DATE OF REVISION: NO INTERVENTION PROVIDED DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: DIAGNOSTIC INTERVENTION: YES SPECIFY: NCV/EMG. DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 550036100 LOT NUMBER: MI191184 COMPONENT TYPE: LINER UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER: 550310015 LOT NUMBER: 230230 COMPONENT TYPE: SCREW UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER: 550000360 LOT NUMBER: 661634 COMPONENT TYPE: SHELL UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER: 550536104 LOT NUMBER: 351208 COMPONENT TYPE: GLENOSPHERE UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER: 520000036 LOT NUMBER: 662988 COMPONENT TYPE: HUMERAL UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER: 550310030 LOT NUMBER: 239924 COMPONENT TYPE: SCREW UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER: 550310020 LOT NUMBER: 219917 COMPONENT TYPE: SCREW UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER: 550025600 LOT NUMBER: 234397 COMPONENT TYPE: SCREW UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER:

  Patient problems: Loss of Range of Motion; Nerve Damage

  MAUDE report 25325116 ↗
• MalfunctionMar 4, 2026Difficult to Insert

  IT WAS REPORTED THAT TWO STAR DRIVE 20 SCREW DRIVERS WERE STRIPPED/TIP BROKE OFF DURING USE. A SMALL PIECE OF THE SCREW DRIVER WAS LEFT IN THE GLENOSPHERE BECAUSE IT COULDN'T BE RETRIEVED. NEED TO BE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24508013 ↗
• InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO SHOULDER WAS INFECTED, SURGEON PULLED COMPONENTS. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 24039323 ↗
• 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 22522968 ↗
• MalfunctionMay 29, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT WHILE INSERTING A SMALL MODULAR BASEPLATE AND LOCKING SCREW INFERIORLY, THE LOCKING SCREW DID NOT CATCH IN THE BASEPLATE; IT SUNK THROUGH. ANOTHER LOCKING SCREW WAS TRIED, AND IT DID THE SAME THING. THE BASEPLATE WAS LEFT IN PLACE ALONG WITH THE SECOND LOCKING SCREW. TWO PERIPHERAL SCREWS WERE ALSO PLACED; THEY LOCKED IN WITH NO ISSUES. DOE: (B)(6) 2025. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22108342 ↗
• MalfunctionMay 29, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT WHILE INSERTING A SMALL MODULAR BASEPLATE AND LOCKING SCREW INFERIORLY, THE LOCKING SCREW DID NOT CATCH IN THE BASEPLATE; IT SUNK THROUGH. ANOTHER LOCKING SCREW WAS TRIED, AND IT DID THE SAME THING. THE BASEPLATE WAS LEFT IN PLACE ALONG WITH THE SECOND LOCKING SCREW. TWO PERIPHERAL SCREWS WERE ALSO PLACED; THEY LOCKED IN WITH NO ISSUES. DOE: (B)(6) 2025. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22108327 ↗
• MalfunctionMay 27, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE SCREW HEAD BROKE OFF WHILE SCREWING INTO THE BASEPLATE. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22087423 ↗