Arthrex® AR-9339-16Recalls & reported problems

Arthrex, Inc. · ARTHREX ECLIPSE HUMERAL HEAD, 39/16 · 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 00888867059962), received between Nov 22, 2022 and Nov 22, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.

Most reported problems

Device problems

Insufficient Device Problem Information1

Patient problems

Insufficient Information1

Recent adverse event reports

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

InjuryNov 22, 2022Insufficient Device Problem Information
ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9301-01 ECLIPSE CAGE SCREW, AN AR-9301-39CPC ECLIPSE TRUNION, AND AN AR-9339-16 ECLIPSE HUMERAL HEAD WERE IMPLANTED. THE SURGEON DEEMED IT NECESSARY TO EXPLANT THE ECLIPSE TRUNION, CAGE SCREW, AND HUMERAL HEAD, AND UPGRADE TO APEX STEMMED IMPLANT DUE TO BONE QUALITY ISSUES. THIS WAS DISCOVERED DURING AN ANATOMIC TOTAL SHOULDER REPLACEMENT PROCEDURE ON (B)(6) 2022.
Patient problems: Insufficient Information
MAUDE report 15842785 ↗

Device details

UDI-DI	`00888867059962`
Brand	Arthrex®
Model	AR-9339-16
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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