INHANCE 5155-00-240Recalls & reported problems
Depuy (Ireland) · INHANCE SHOULDER SYSTEM CONVERTIBLE GLENOID SMALL X-LINKED VITAMIN E PE CAUTION:USE WITH MODULAR OR R/SPEED UNITI PLATFORM BASEPLATE Ø24mm · Class 2 · Implant
All models of INHANCE (202)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295551645), received between Oct 15, 2025 and Feb 5, 2026 — classified as 2 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 Problem2
Patient problems
- Muscle/Tendon Damage1
- Unspecified Tissue Injury1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
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 24270341 ↗InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION RECEIVED: TREATMENT/IMPACT: REHABILITATION, INJECTED MEDICATION (SPECIFY: 2 ML OF 1% LIDOCAINE 2 ML OF 0.25% MARCAINE AND 2 ML OF BETAMETHASONE) AND ORAL/TOPICAL MEDICATION (SPECIFY: MEDROL DOSEPAK), OUTCOME: RECOVERING/RESOLVING.
Patient problems: Muscle/Tendon Damage
MAUDE report 23285912 ↗
Other prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented devices
- Comprehensive Reverse Shoulder 115310Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 death99 reports
- INHANCE 5120-00-110Depuy (Ireland) · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented75 reports
- Comprehensive® Reverse Shoulder XL-115364Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 recall7 reports
- Comprehensive® Reverse Shoulder XL-115366Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 recall4 reports
- Comprehensive® Reverse Shoulder 180550Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented2 deaths43 reports
- Comprehensive® Reverse Shoulder 180551Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented42 reports
- DJO SURGICAL 521-07-246Encore Medical, L.P. · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented42 reports
- Comprehensive® 110031399Zimmer, Inc. · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 death36 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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