INHANCE 5200-44-152Recalls & reported problems
Depuy (Ireland) · INHANCE SHOULDER SYSTEM HUMERAL HEAD diameter 44mm X 15.25mm · Class 2 · Implant
All models of INHANCE (202)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295538349), received between May 5, 2023 and Sep 15, 2026 — classified as 9 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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 Problem7
- Device Dislodged or Dislocated2
Patient problems
- Unspecified Tissue Injury6
- Joint Dislocation2
- Pain2
- Swelling/ Edema1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
InjurySep 15, 2026Device Dislodged or Dislocated
It was reported that the patient underwent an anatomic inhance on Thursday. This patient had a history of seizure activity and recurrent dislocations. Patient dislocated shortly after Inhance anatomic procedure and was converted to an inhance reverse on Sunday.Affected side: Right Shoulder.
Patient problems: Joint Dislocation
MAUDE report 50773402 ↗InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem
It was reported that soft tissue failed. No mechanical issue with implants.DOI: (b)(6) 2026.DOR: (b)(6) 2026.Affected side: Unknown.
Patient problems: Unspecified Tissue Injury
MAUDE report 50045737 ↗InjuryJun 8, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT WAS HAVING PAIN AND SWELLING. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT SHOULDER.
Patient problems: Pain; Swelling/ Edema
MAUDE report 25434488 ↗InjuryApr 15, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT FAILED ROTATOR CUFF. CONVERTED TO REVERSE. AFFECTED SIDE: UNKNOWN.
Patient problems: Unspecified Tissue Injury
MAUDE report 24885009 ↗InjuryFeb 5, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT¿S ROTATOR CUFF FAILED AND NEEDED TO BE CONVERTED TO REVERSE. THE CONVERTIBLE POLY WAS REMOVED ALONG WITH THE HUMERAL HEAD AND OFFSET TAPER ADAPTER. A GLENOSPHERE WAS OPENED AND IMPLANTED. TRIAL SHELL WAS USED ON THE EXISTING STEMMED IMPLANT AND THE SHOULDER WAS REDUCED. STABILITY WAS SATISFACTORY, SO THE REAL SHELL AND POLY WERE OPENED AND IMPLANTED. NO DELAYS OR ADVERSE EVENTS TOOK PLACE. ACTIVITY LEVEL - YES DOI: (B)(6) 2025, DOR: UNKNOWN, AFFECTED SIDE: RIGHT SHOULDER.
Patient problems: Unspecified Tissue Injury
MAUDE report 24270333 ↗InjuryJan 14, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT TOTAL SHOULDER CONVERSION FROM ANATOMIC TO REVERSE ARTHROPLASTY RELATED TO GLENOID IMPLANT DISASSOCIATED. AFFECTED SIDE: RIGHT SHOULDER.
Patient problems: Joint Dislocation
MAUDE report 24066709 ↗InjuryMar 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO ROTATOR CUFF PAIN. DOI: UNKNOWN; DOR: (B)(6) 2024 AFFECTED SIDE : RIGHT SHOULDER.
Patient problems: Pain; Unspecified Tissue Injury
MAUDE report 18907232 ↗InjuryDec 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED DUE TO SUBSCAPULARIS FAILURE AND THE IMPLANTS WERE CONVERTED TO A REVERSE. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6), 2023. DOR: (B)(6), 2023. AFFECTED SIDE: RIGHT SHOULDER.
Patient problems: Unspecified Tissue Injury
MAUDE report 18300334 ↗InjuryMay 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD A SUBSCAPULARIS FAILURE. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT SHOULDER.
Patient problems: Unspecified Tissue Injury
MAUDE report 16875334 ↗
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.
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