INHANCE 5200-00-044Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295538288), received between Jul 9, 2025 and Feb 11, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 11, 2026Migration

  SUBJECT ID: (B)(6). STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR IMPLANT SHIFT DEVICE RELATED: CASUAL RELATIONSHIP (HUMERAL STEMLESS IMPLANT: YES) PROCEDURE RELATED: POSSIBLE DATE OF EVENT: (B)(6) 2026 DATE OF IMPLANT: (B)(6) 2025 DATE OF REVISION: NO INFORMATION PROVIDED DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: OBSERVATION. DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 550011240 LOT NUMBER: 66451 COMPONENT TYPE: BASEPLATE DESCRIPTION: ENHANCE SHOULDER SYSTEM MODULAR UNITI PLATFORM BASEPLATE SMALL Ø24MM CEMENTLESS. CATALOG NUMBER: 550035600 LOT NUMBER: 237381 COMPONENT TYPE: SCREW DESCRIPTION: INHANCE SHOULDER SYSTEM CENTRAL SCREW Ø6.0 X 35MM. CATALOG NUMBER: 550310035 LOT NUMBER: 229426 COMPONENT TYPE: SCREW DESCRIPTION: INHANCE SHOULDER SYSTEM LOCKING SCREW 35MM. CATALOG NUMBER: 550310025 LOT NUMBER: 233600 COMPONENT TYPE: SCREW DESCRIPTION: INHANCE SHOULDER SYSTEM LOCKING SCREW 25MM. CATALOG NUMBER: 550310035 LOT NUMBER: 223956 COMPONENT TYPE: SCREW DESCRIPTION: INHANCE SHOULDER SYSTEM LOCKING SCREW 35MM. CATALOG NUMBER: 550540008 LOT NUMBER: 333136 COMPONENT TYPE: GLENOSPHERE DESCRIPTION: INHANCE SHOULDER SYSTEM GLENOSPHERE Ø40+8MM. CATALOG NUMBER: 520000044 LOT NUMBER

  Patient problems: Insufficient Information

  MAUDE report 24313218 ↗
• MalfunctionJul 9, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE PATIENT HAD A LEFT TOTAL SHOULDER ARTHROPLASTY. IT WAS DECIDED TO DO AN XLG STEMLESS IMPLANT. SIZING, REAMING, AND BLAZING WERE DONE WITH THE XLG. WHEN IMPLANTING THE XLG STEMLESS IMPLANT, THE SURGEON COULD NOT GET THE IMPLANT TO PROGRESS TO SEATING ON THE FLUSH HUMERAL SURFACE. THE PHYSICIAN WAS NOT COMFORTABLE ADVANCING THE XLG IMPLANT FURTHER WITH THE MALLET AS THEY FELT IT RISKED FRACTURING THE HUMERUS. SURGEON CHOSE TO DOWN SIZE TO A LARGE STEMLESS IMPLANT WHICH THEY FELT WAS GOOD FIXATION AND WAS ABLE TO ADVANCE IT TO THE FLUSH HUMERAL SURFACE. IT WAS NOTED THAT THE PATIENT HAD DENSE/GOOD BONE. DOE: (B)(6) 2025. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22460954 ↗