Arthrex® AR-9301-39CPCRecalls & reported problems

Arthrex, Inc. · ECLIPSE TRUNION 39MM, SLOTTED, TPS CaP · Class 2 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 2
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867276123), received between Nov 22, 2022 and Mar 24, 2026 — classified as 2 injuries.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

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

Most reported problems

Device problems

Insufficient Device Problem Information1
Patient Device Interaction Problem1

Patient problems

Insufficient Information2
Erosion1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

InjuryMar 24, 2026Patient Device Interaction Problem
ON 04-MAR-2026, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT A PATIENT UNDERWENT A REVISION FROM ECLIPSE + VAULTLOCK TSA TO RTSA ON (B)(6) 2026. THE PATIENT¿S ORIGINAL SURGERY DATE WAS ON (B)(6) 2024. THE REVISION WAS PERFORMED DUE TO SUBSCAPULARIS FAILURE AND NOT DUE TO FAILURE OF THE ECLIPSE OR VAULTLOCK IMPLANTS. HOWEVER, SIGNIFICANT VAULTLOCK EROSION WAS NOTED AT LESS THAN TWO YEARS POST-IMPLANTATION. THE ARTHREX IMPLANTS EXPLANTED DURING THE REVISION INCLUDED: AR-9106-01 ARTHREX UNIVERS VAULTLOCK GLENOID, SMALL, AR-9301-02 ARTHREX ECLIPSE CAGE SCREW MEDIUM (35.0 MM), AR-9301-39CPC ARTHREX ECLIPSE TRUNION 39 MM, SLOTTED, TPS CAP, AND AN AR-9339-18 ARTHREX ECLIPSE HUMERAL HEAD, 39/18. ADDITIONAL INFORMATION WAS RECEIVED ON 10-MAR-2026: THE PATIENT WAS INITIALLY TREATED ON (B)(6) 2024 FOR A SUBSCAPULARIS TEAR SUSTAINED DURING A PHYSICAL ALTERCATION. DURING THE REVISION, ANTERIOR EROSION MEASURING APPROXIMATELY 2¿3 MM WAS OBSERVED. THE SURGEON DID NOT COMMENT ON WHETHER THE EROSION CONTRIBUTED TO THE NEED FOR REVISION OR IF IT WAS AN INCIDENTAL FINDING. THE REVISION PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CASE DELAY AND NO ADDITIONAL ANESTHESIA REPORTED. NO FURTHER SURGERIE
Patient problems: Erosion; Insufficient Information
MAUDE report 24673724 ↗
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 15842802 ↗

Device details

UDI-DI	`00888867276123`
Brand	Arthrex®
Model	AR-9301-39CPC
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): Coated shoulder humeral stem prosthesis

A sterile implantable device designed to provide fixation within the proximal humerus and a site of attachment for a humeral head or humeral body prosthesis as part of a shoulder joint replacement. The device is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. 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 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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