Arthrex® AR-9347-20Recalls & reported problems

Arthrex, Inc. · ARTHREX ECLIPSE HUMERAL HEAD, 47/20 · Class 2 · Implant

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

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867060050), received between Aug 25, 2021 and Aug 25, 2021 — classified as 1 malfunction.

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.

Most reported problems

Device problems

Adverse Event Without Identified Device or Use Problem1

Patient problems

Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1

Recent adverse event reports

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

MalfunctionAug 25, 2021Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SHOULDER PROCEDURE ON (B)(6) 2021 WHERE AN ARTHREX IMPLANT WAS REMOVED. NO FURTHER DETAILS, ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION PROVIDED 8/19/2021: THE DATE OF THE PRIMARY PROCEDURE WAS ON (B)(6) 2021 FOR A LEFT TOTAL SHOULDER ARTHROPLASTY. THIS PROCEDURE TOOK PLACE AT (B)(6), ARTHREX ACCOUNT #(B)(4). REVISION FOR A LEFT ANATOMIC TOTAL SHOULDER ARTHROPLASTY TO REVERSE SHOULDER ARTHROPLASTY TOOK PLACE AT ARTHREX ACCOUNT #(B)(4) ON (B)(6) 2021 WHERE THE FOLLOWING DEVICES WERE EXPLANTED: AR-9301-02 (20.00960); AR-9301-47CPC (19.04096); AR-9347-20 (2797, 47/20); AR-9121-06 (17.01402).
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 12364473 ↗

Device details

UDI-DI	`00888867060050`
Brand	Arthrex®
Model	AR-9347-20
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

Arthrex® AR-9301-03
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12 reports
Arthrex® AR-9301-01
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9 reports
Arthrex® AR-9349-18
Arthrex, Inc. · Total shoulder arthroplasty system
9 reports
Arthrex® AR-9343-16
Arthrex, Inc. · Total shoulder arthroplasty system
7 reports
Arthrex® AR-9347-18
Arthrex, Inc. · Total shoulder arthroplasty system
7 reports
Arthrex® AR-9345-17
Arthrex, Inc. · Total shoulder arthroplasty system
6 reports
Arthrex® AR-9301-02
Arthrex, Inc. · Total shoulder arthroplasty system
6 reports
Arthrex® AR-9341-16
Arthrex, Inc. · Total shoulder arthroplasty system
5 reports

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 16, 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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