Arthrex® AR-9301-04Recalls & reported problems

Arthrex, Inc. · ECLIPSE CAGE SCREW XL, 45MM · Class 2 · Implant

Data updated Oct 13, 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 00888867059955), received between Jul 26, 2024 and Jul 26, 2024 — 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. How this data works · Data updated Oct 13, 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.

InjuryJul 26, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
IT WAS REPORTED THAT A REVISION SURGERY WAS NECESSARY DUE TO A METALLOSIS. THE IMPLANT WAS IMPLANTED FOUR YEARS AGO WITH BONE GRAFT AUGMENTATION.. NO FURTHER INFORMATION WAS PROVIDED. UPDATE DW 12-JUL-2024: FURTHER INFORMATION WERE PROVIDED THAT DURING AN INITIAL SURGERY ON (B)(6) 2020 THE FOLLOWING DEVICES WERE IMPLANTED DUE TO AN OMARTHROSIS WITH B2 GLENOID SITUATION WITH A RETRO OF JUST UNDER 30 DEGREES. AR-9120-03, AR-9165-25NL, AR-9145-36, AR-9121-03, AR-9300-45CPC, AR-9301-04. ON (B)(6) 2024 THE REVISION SURGERY WAS PERFORMED. AS PART OF THE REVISION THE ECLIPSE AND UNIVERSAL GLENOID WERE ALL REMOVED DUE TO A SEVERE METALLOSIS. THE SURGEON DECIDED TO FIRST BUILD UP THE GLENOID WITH ALLOGRAFT IN A TWO-SIDED PROCEDURE AND TO INSERT A CEMENT SPACER ON THE HUMERUS SIDE. IN THE SECOND STEP - A UNIVERS REVERSE WILL BE INSERTED IN AUTUMN WITH PLANNING.
Patient problems: Metal Related Pathology
MAUDE report 19837918 ↗

Device details

UDI-DI	`00888867059955`
Brand	Arthrex®
Model	AR-9301-04
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	Jun 3, 2021

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.

Other Total shoulder arthroplasty system devices

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Arthrex® AR-9347-18
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Arthrex® AR-9343-16
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Arthrex® AR-9301-02
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Arthrex® AR-9345-17
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Arthrex® AR-9341-16
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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 13, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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