Arthrex® AR-9300-49CPCRecalls & reported problems

Arthrex, Inc. · ECLIPSE TRUNION,49 MM TPS CTD · Class 2 · Implant

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867059894), received between Dec 30, 2025 and Dec 30, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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 16, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Patient Device Interaction Problem1

Patient problems

Metal Related Pathology1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjuryDec 30, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
IT WAS REPORTED THAT THE PE INLAY AR-9121-02 OF THE UNIVERSAL GLENOID GOT WORN OFF, RESULTING IN METAL ON METAL CONTACT BETWEEN ECLIPSE HUMERAL HEAD AND THE BASEPLATE OF THE UNIVERSAL GLENOID. THIS RESULTED IN METALLOSES AND RELATED PROBLEMS REQUIRING A REVISION SURGERY WITH A CONVERSION TO A REVERSE PROSTHESIS. DURING THE REVISION SURGERY THE ECLIPSE HUMERAL COMPONENTS AND THE REMAINING PARTS OF THE INLAY WERE REMOVED AND PROPER SEATING OF THE UNIVERSAL GLENOID BASEPLATE WAS CONFIRMED. THEN A GLENOSPHERE WAS INSERTED ONTO THE BASEPLATE AND THE UNIVERS REVERS HUMERAL COMPONENTS WERE IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Metal Related Pathology
MAUDE report 23927376 ↗

Device details

UDI-DI	`00888867059894`
Brand	Arthrex®
Model	AR-9300-49CPC
Company	Arthrex, Inc.
Product code	QHQ · Total shoulder arthroplasty system
Class	Class 2
FDA submission	None listed
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Conditional
Status	In Commercial Distribution
Record updated	Feb 9, 2026

Device type (GMDN): Total shoulder prosthesis

A sterile implantable artificial substitute for a shoulder joint designed to replace both articulating surfaces of the damaged (e.g., fractured) and/or degenerative (e.g., arthritic) joint. It includes glenoid and humeral (head and stem) components typically with parts made of metal and polyethylene (PE). Fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement.

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All Total shoulder arthroplasty system devices →

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 13, 2026
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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