Arthrex® AR-9351-19Recalls & reported problems

Arthrex, Inc. · ARTHREX ECLIPSE HUMERAL HEAD, 51/19 · Class 2 · Implant

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 00888867060081), received between Nov 17, 2025 and Nov 17, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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

Loosening of Implant Not Related to Bone-Ingrowth1

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.

InjuryNov 17, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 DUE TO LOOSENING OF THE GLENOID COMPONENT AND PERSISTENT PAIN REPORTED BY THE PATIENT. INTRAOPERATIVELY, PRONOUNCED METALLOSIS WAS DETECTED. THE POLYETHYLENE (PE) INLAY EXHIBITED SIGNIFICANT EROSION, AND THE UNIVERSAL BASEPLATE WAS FOUND TO BE PARTIALLY ERODED AS WELL. ALL COMPONENTS AND ASSOCIATED FRAGMENTS WERE REMOVED. SUBSEQUENTLY, A REVERSE SHOULDER PROSTHESIS (UNIVERS REVERS COMBINED WITH THE MODULAR GLENOID SYSTEM) WAS IMPLANTED.
Patient problems: Metal Related Pathology
MAUDE report 23569529 ↗

Device details

UDI-DI	`00888867060081`
Brand	Arthrex®
Model	AR-9351-19
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
Arthrex, Inc. · Total shoulder arthroplasty system
12 reports
Arthrex® AR-9301-01
Arthrex, Inc. · Total shoulder arthroplasty system
9 reports
Arthrex® AR-9349-18
Arthrex, Inc. · Total shoulder arthroplasty system
9 reports
Arthrex® AR-9347-18
Arthrex, Inc. · Total shoulder arthroplasty system
7 reports
Arthrex® AR-9343-16
Arthrex, Inc. · Total shoulder arthroplasty system
7 reports
Arthrex® AR-9301-02
Arthrex, Inc. · Total shoulder arthroplasty system
6 reports
Arthrex® AR-9345-17
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.