INHANCE 5200-00-028Recalls & reported problems
Depuy (Ireland) · INHANCE SHOULDER SYSTEM STEMLESS X-SMALL DIAMETER 28mm CEMENTLESS · Class 2 · Implant
All models of INHANCE (202)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295538271), received between Jul 12, 2023 and Jun 15, 2026 — classified as 3 injuries.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem3
Patient problems
- Unspecified Tissue Injury3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJun 15, 2026Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO INJURY AND RHEUMATOID ARTHRITIS. THE PATIENT FELL AND INJURED THEIR SUB SCAP RESULTING IN THE REVISION TO A RESERVE SHOULDER. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT SHOULDER.
Patient problems: Unspecified Tissue Injury
MAUDE report 25504806 ↗InjuryJul 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD SUBSCAP EVULSION AND REQUIRED REVISION TO REVERSE. DOI: UNKNOWN. DOR: ON (B)(6) 2024. AFFECTED SIDE: LEFT SHOULDER.
Patient problems: Unspecified Tissue Injury
MAUDE report 19816847 ↗InjuryJul 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD A LEFT TSA WITH INHANCE STEMLESS AND GLENOID. AT THAT TIME THE CASE WAS SCHEDULED AS TSA VS RTSA DUE TO THE QUALITY OF THE SUBSCAP. IT WAS DECIDED THE SUBSCAP HAD FAILED AND THE PATIENT HAD EXPLANTAION OF INHANCE TSA, ALL COMPONENTS, WITH CONVERSION TO ARTHREX REVERSE TSA. DOI: (B)(6) 2023; DOR: (B)(6) 2023; AFFECTED SIDE: LEFT SHOULDER.
Patient problems: Unspecified Tissue Injury
MAUDE report 17309660 ↗
Other Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained devices
- Tornier Perform DWM003ATornier, Inc. · Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained1 recall1 report
- Sidus® Stem-Free Shoulder 01.04555.500Zimmer GmbH · Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained1 recall1 report
- DJO SURGICAL 520-08-021Encore Medical, L.P. · Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained20 reports
- INHANCE 5200-00-036Depuy (Ireland) · Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained17 reports
- Easytech Anatomical Shoulder System 314-0038Fx Solutions · Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained14 reports
- Tornier Simpliciti® Shoulder System 7122872Tornier, Inc. · Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained9 reports
- Sidus® Stem-Free Shoulder 01.04555.110Zimmer GmbH · Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained6 reports
- GLOBAL ICON 1140-10-054Depuy (Ireland) · Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained6 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page