INHANCE 5503-10-040Recalls & reported problems
Depuy (Ireland) · INHANCE SHOULDER SYSTEM LOCKING SCREW 40mm · Class 2 · Implant
All models of INHANCE (202)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295546610), received between Jan 21, 2025 and Jan 27, 2026 — classified as 3 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Fracture” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem3
- Fracture3
Patient problems
- Foreign Body In Patient2
- No Clinical Signs, Symptoms or Conditions2
- Unspecified Infection2
- Joint Laxity1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryJan 27, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A REVERSED TOTAL SHOULDER REVISION OCCURRED DUE TO GLENOSPHERE AND LINER IMPINGEMENT. PATIENT WAS CONVERTED TO HEMI ARTHOPLASTY. DURING THE PROCEDURE THE HEAD TRIAL WAS DAMAGED WHERE THE ADAPTOR FOR HEAD AND TRIAL MEET. THE ATTACHMENT TABS BROKE OFF. THERE WAS NO HARM TO PATIENT AND NO SURGICAL DELAY. DOE: (B)(6) 2026. AFFECTED SIDE: RIGHT SHOULDER.
Patient problems: Joint Laxity
MAUDE report 24187908 ↗MalfunctionSep 4, 2025Fracture; Fracture
IT WAS REPORTED THAT LOCKING HEAD BROKE FLUSH OFF THE SCREW WHEN LOCKING INTO BASEPLATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22965181 ↗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 22644816 ↗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 22644793 ↗MalfunctionMay 22, 2025Fracture; Fracture
IT WAS REPORTED THAT THE HEAD OF THE SCREW BROKE OFF UPON INSERTION DURING A PRIMARY SHOULDER REPAIR. THE BROKEN SCREW WAS LEFT IN PLACE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 22068817 ↗MalfunctionJan 21, 2025Fracture; Fracture
IT WAS REPORTED THAT ENHANCE LOCKING SCREW HEAD BROKE WHILE ADVANCING/TRYING TO BACK OUT. REMAINING SCREW WAS BURRED OFF AND CASE WAS COMPLETED. THE SURGICAL DELAY IS UNKNOWN. DOE: (B)(6) 2025. AFFECTED SIDE: UNKNOWN SHOULDER.
Patient problems: Foreign Body In Patient
MAUDE report 21198156 ↗
Other PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED devices
- DJO SURGICAL 509-02-032Encore Medical, L.P. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED364 reports
- DELTA XTEND 130790036Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED171 reports
- DELTA XTEND 130770018Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED159 reports
- TRIGEN 71118200Smith & Nephew, Inc. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED123 reports
- DJO SURGICAL 509-02-432Encore Medical, L.P. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED119 reports
- DELTA XTEND 130738206Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED116 reports
- COMPREHENSIVE SHOULDER SYSTEM 113633Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED2 recalls4 reports
- DELTA XTEND 130742206Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED99 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