Arthrex® AR-9339-18Recalls & reported problems
Arthrex, Inc. · ARTHREX ECLIPSE HUMERAL HEAD, 39/18 · Class 2 · Implant
- 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 00888867059979), received between Jun 3, 2020 and Mar 24, 2026 — classified as 2 injuries.
The most frequently reported specific device problem is “Break” (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
Most reported problems
Device problems
- Break1
- Patient Device Interaction Problem1
Patient problems
- Erosion1
- Insufficient Information1
- Loss of Range of Motion1
- Pain1
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 (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 SURGERIES A
Patient problems: Erosion; Insufficient Information
MAUDE report 24679942 ↗InjuryJun 3, 2020Break
AN ARTHREX EMPLOYEE HAS REPORTED THAT AFTER 1 YEAR AND 7 MONTH AFTER INITIAL SURGERY A REVISION SURGERY TOOK PLACE. ACCORDING TO SURGEON THE ROTATOR CUFF WAS IRREPARABLE AND THEREFORE IT WAS CHANGED FROM AN ANATOMIC TO AN INVERSE PROTHESIS. THE ECLIPSE HAD SETTLED IN WELL AND SHOWED NO SIGN OF LOOSENING. THE GLENOID WAS NOT SUPPLIED WITH THE ECLIPSE WHEN IT WAS FITTED. THE SUPPLY WITH A UNIVERS REVERS WENT VERY WELL. UPDATE 25-MAY-2020: FURTHER INFORMATION PROVIDED THAT THE REVISION WAS NEEDED AS THE PATIENT SUFFERED PAIN AND WAS NOT ABLE TO RISE THE ARM ANYMORE. NO FURTHER INFORMATION IS AVAILABLE AS TO HOW THE DEVICES CONTRIBUTED TO THE REPORTED EVENT.
Patient problems: Loss of Range of Motion; Pain
MAUDE report 10114053 ↗
Other Total shoulder arthroplasty system devices
- Arthrex® AR-9301-03Arthrex, Inc. · Total shoulder arthroplasty system12 reports
- Arthrex® AR-9301-01Arthrex, Inc. · Total shoulder arthroplasty system9 reports
- Arthrex® AR-9349-18Arthrex, Inc. · Total shoulder arthroplasty system9 reports
- Arthrex® AR-9347-18Arthrex, Inc. · Total shoulder arthroplasty system7 reports
- Arthrex® AR-9343-16Arthrex, Inc. · Total shoulder arthroplasty system7 reports
- Arthrex® AR-9301-02Arthrex, Inc. · Total shoulder arthroplasty system6 reports
- Arthrex® AR-9345-17Arthrex, Inc. · Total shoulder arthroplasty system6 reports
- Arthrex® AR-9341-16Arthrex, Inc. · Total shoulder arthroplasty system5 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.