INHANCE 5500-40-600Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295548812), received between May 15, 2023 and Oct 15, 2025 — classified as 3 injuries.

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

• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CLINICAL ADVERSE EVENTS WERE RECEIVED FOR CONJOINED TENDINITIS: DEVICE AND PROCEDURE(RELATEDNESS) DEVICE RELATED: NOT RELATED, PROCEDURE RELATED: POSSIBLE, DATE OF EVENT: 05 SEP 2025, DATE OF IMPLANT: (B)(6) 2025, DATE OF REVISION: NO INFORMATION PROVIDED, DEVICE LOCATION: NO INFORMATION PROVIDED. SUBJECT ID: (B)(6), STUDY NO: (B)(6). TREATMENT/IMPACT: REHABILITATION, INJECTED MEDICATION (SPECIFY: 2 ML OF 1% LIDOCAINE 2 ML OF 0.25% MARCAINE AND 2 ML OF BETAMETHASONE) AND ORAL/TOPICAL MEDICATION DEPUY SYNTHES PRODUCT USED: CATALOG NUMBER: 520000036, LOT NUMBER: 662705, COMPONENT TYPE: HUMERAL, UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER: 550011240, LOT NUMBER: 66395,1 COMPONENT TYPE: BASEPLATE, UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER: 550300500, LOT NUMBER: 229406, COMPONENT TYPE: SCREW, UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER: 550040600, LOT NUMBER: 206414, COMPONENT TYPE: SCREW, UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER: 550532008, LOT NUMBER: 347232, COMPONENT TYPE: GLENOSPHERE, UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER: 550000360, LOT NUMBER: 664116, COMPONENT TYPE: SHELL, UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER: 550032000, LOT NUMBER: MI1777, COMPONENT TYPE

  Patient problems: Muscle/Tendon Damage

  MAUDE report 23285890 ↗
• 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 22978139 ↗
• InjuryMay 15, 2023Osseointegration Problem; Osseointegration Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO ASEPTIC LOOSENING. DOI: (B)(6) 2023; DOR: (B)(6) 2023; RIGHT SHOULDER. TREATMENT: METAGLENE AND GLENOSPHERE WERE REVISED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 16935811 ↗