INHANCE 5200-48-195Recalls & reported problems
Depuy (Ireland) · INHANCE SHOULDER SYSTEM HUMERAL HEAD diameter 48.5mm X 19.5mm · Class 2 · Implant
All models of INHANCE (202)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295538394), received between Aug 23, 2023 and Jun 30, 2026 — classified as 4 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem3
- Device Dislodged or Dislocated1
Patient problems
- Unspecified Tissue Injury3
- Joint Laxity2
- Joint Dislocation1
- Pain1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJun 30, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT HEMI REVISED DUE TO FAILED ROTATOR CUFF/CHRONIC SUBLUXATION. AFFECTED SIDE: RIGHT SHOULDER.
Patient problems: Joint Laxity; Unspecified Tissue Injury
MAUDE report 25667553 ↗InjuryAug 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT TORE SUBSCAPULARIS SO THE SURGEON REPAIRED AND WENT WITH A SMALLER PROFILE OF HUMERAL HEAD. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: UNKNOWN SHOULDER.
Patient problems: Unspecified Tissue Injury
MAUDE report 22877110 ↗InjuryMay 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT HAD SHOULDER AND NECK PAIN. DOI: UNKNOWN . DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN SHOULDER.
Patient problems: Pain
MAUDE report 22041088 ↗InjuryAug 23, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT WAS CONVERTED TO A REVERSE SHOULDER AS THE SURGEON STATED THAT HE BELIEVED THE PATIENT TORE HER RC DURING THERAPY AND MADE THE JOINT UNSTABLE AND WAS ROCKING THE GLENOID IMPLANT AND IT LOOSENED AND BECAME DISLODGED. LOOSENING OF THE GLENOID COMPONENT AT THE BONE TO CEMENT INTERFACE WAS REPORTED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2023 DOR: (B)(6) 2023 AFFECTED SIDE: LEFT SHOULDER.
Patient problems: Joint Dislocation; Joint Laxity; Unspecified Tissue Injury
MAUDE report 17606874 ↗
Other PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED devices
- DJO SURGICAL 508-32-204Encore Medical, L.P. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall544 reports
- Comprehensive Reverse Shoulder 010000589Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall142 reports
- DELTA XTEND 130738203Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED175 reports
- DJO SURGICAL 509-00-432Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 recall117 reports
- Alliance® SBGL3007Zimmer, Inc. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED162 reports
- DELTA XTEND 130760138Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED146 reports
- DELTA XTEND 130790030Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED132 reports
- DJO SURGICAL 509-00-436Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented124 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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