Arthrex® AR-9301-47CPCRecalls & reported problems
Arthrex, Inc. · ECLIPSE TRUNION 47MM, SLOTTED, TPS CaP · Class 2 · Implant
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867276161), received between Jun 1, 2021 and Jun 6, 2025 — classified as 2 injuries, 1 malfunction.
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
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Loosening of Implant Not Related to Bone-Ingrowth1
- Patient Device Interaction Problem1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Failure of Implant1
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJun 6, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
ON 04/15/2025, A CLINDEX NOTIFICATION WAS RECEIVED VIA EMAIL INDICATING THAT A PATIENT LISTED IN THE SHOULDER ARTHROPLASTY REGISTRY EXPERIENCED A SUBSCAPULARIS FAILURE. AS A RESULT, THE PATIENT UNDERWENT A REVISION PROCEDURE, CONVERTING TO A DIFFERENT TYPE OF ARTHROPLASTY. THE INITIAL ECLIPSE PROCEDURE HAD BEEN PERFORMED ON (B)(6) 2024. THE EVENT WAS DETERMINED TO BE UNRELATED TO THE ORIGINAL SURGERY. ADDITIONAL INFORMATION RECEIVED ON 05/14/2025: DURING THE REVISION SURGERY ON (B)(6) 2025, AN AR-9347-18 ARTHREX ECLIPSE HUMERAL HEAD, AN AR-9301-03 ARTHREX ECLIPSE CAGE SCREW LARGE, AN AR-9301-47CPC ARTHREX ECLIPSE TRUNION, AND AN AR-9106-03 ARTHREX UNIVERS VAULTLOCK GLENOID WERE EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 22162006 ↗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 GATEWAY SURGERY CENTER, 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 12364462 ↗InjuryJun 1, 2021Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT THE AR-9301-03 AND AR-9301-47CPC WERE IMPLANTED FOR A TOTAL SHOULDER CASE; PATIENT IS FEMALE, 60S. AFTER THE IMPLANT, THE SURGEON WAS CHECKING THE FIT; IT WAS LOOSE AND BOTH DEVICES PULLED OUT OF THE PATIENT WITH BONE MATTER ATTACHED TO IT. THEY CONVERTED THE CASE TO APEX AND IT WAS COMPLETED.
Patient problems: Insufficient Information
MAUDE report 11912022 ↗
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.