INHANCE 5505-05-290Recalls & reported problems
Depuy (Ireland) · INHANCE SHOULDER SYSTEM R/SPEED UNITI Baseplate LARGE Ø29mm CEMENTLESS · 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 10603295550396), received between Mar 20, 2024 and Dec 24, 2025 — classified as 4 injuries.
The most frequently reported specific device problem is “Fracture” (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
- Fracture1
Patient problems
- Unspecified Infection3
- Pain1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryDec 24, 2025Fracture; Fracture
IT WAS REPORTED THE PATIENT PRESENTED ON (B)(6) 2025 WITH INCREASING SHOULDER PAIN AFTER INHANCE REVISION WITH MONOLITHIC IMPLANT ON (B)(6) 2025. X-RAYS REVEAL BROKEN CENTRAL SCREW.
Patient problems: Pain
MAUDE report 23889020 ↗InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR INFECTION. THE INFECTED PRODUCTS WERE EXPLANTED.
Patient problems: Unspecified Infection
MAUDE report 23814235 ↗InjuryJul 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AND THE IMPLANTS NEEDED TO BE REMOVED. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN SHOULDER.
Patient problems: Unspecified Infection
MAUDE report 22649768 ↗InjuryMar 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT INITIAL SURGERY WAS DONE (B)(6) 2023 BY THE SURGEON AT HOSPITAL. PATIENT WAS THEN REVISED DUE TO INSTABILITY ON (B)(6) 2023. THE SURGEON WAS UNABLE TO FIND THE MDR NUMBER FOR THAT FIRST REVISION. UNFORTUNATELY THE PATIENT CAME BACK AGAIN, BUT THIS TIME FOR INFECTION. ALL IMPLANTS WERE REMOVED AND THE SHOULDER WAS THOROUGHLY WASHED. THERE WAS NO SURGICAL DELAYS OR ADVERSE EVENTS TOOK PLACE. THE SHOULDER WAS CLOSED AFTER A THOROUGH WASHOUT. DOI: (B)(6) 2023. DOR: UNKNOWN. AFFECTED SIDE: RIGHT SHOULDER.
Patient problems: Unspecified Infection
MAUDE report 18941031 ↗
Other PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED devices
- COMPREHENSIVE SHOULDER SYSTEM 113629Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED1 recall2 reports
- COMPREHENSIVE SHOULDER SYSTEM 113617Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED1 recall1 report
- Comprehensive® Shoulder System 113607Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED1 recall1 report
- BIO-MODULAR SHOULDER SYSTEM 113865Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED1 recall0 reports
- COPELAND SHOULDER SYSTEM 11-114648Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED1 recall0 reports
- COMPRESS DEVICE 178787Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED1 recall0 reports
- BIO-MODULAR SHOULDER SYSTEM 113863Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED1 recall0 reports
- BIO-MODULAR SHOULDER SYSTEM 113867Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED1 recall0 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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