Arthrex® AR-9345-17Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888867060029), received between Jun 28, 2017 and Mar 12, 2025 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (3 reports).

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.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMar 12, 2025Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  ON 2/17/2025, A CLINDEX NOTIFICATION WAS RECEIVED INDICATING THAT A PATIENT LISTED ON THE SHOULDER ARTHROPLASTY REGISTRY SUFFERED A RUPTURED SUBSCAPULARIS DUE TO A TRAUMATIC FALL. THE PATIENT UNDERWENT REVISION SURGERY OF THE ANATOMIC SHOULDER REPLACEMENT TO A REVERSE SHOULDER ARTHROPLASTY ON (B)(6) 2023. THE EVENT WAS INDICATED AS UNRELATED TO THE ECLIPSE SYSTEM IMPLANTED ON (B)(6) 2023. ADDITIONAL INFORMATION RECEIVED ON 2/27/2025: ON (B)(6) 2023, THE PATIENT UNDERWENT REVISION SURGERY TO HAVE AN AR-9301-45CPC ARTHREX ECLIPSE TRUNION, AN AR-9106-02 ARTHREX UNIVERS VAULTLOCK GLENOID, AN AR-9301-03 ARTHREX ECLIPSE CAGE SCREW LARGE, AND AN AR-9345-17 ARTHREX ECLIPSE HUMERAL HEAD REMOVED. AFTER THE SURGERY, THE PATIENT IS DOING WELL WITH AN EIGHTY-FIVE TO NINETY PERCENT IMPROVEMENT IN SYMPTOMS.

  Patient problems: Failure of Implant; Rupture

  MAUDE report 21586172 ↗
• InjuryJan 8, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2024, IT WAS REPORTED BY THE PATIENT VIA PHONE THAT THE PATIENT HAD THE AR-9345-17 ARTHREX ECLIPSE¿ HUMERAL HEAD, 45/17 EXPLANTED FROM THE PATIENT'S RIGHT SHOULDER FOR A REVISION PROCEDURE ON (B)(6) 2024 DUE TO A BAD ALLERGIC REACTION WITH THE PRODUCT. THE PATIENT HAD VISIBLE ROUND RASHES SPREADING FROM THE EARS, FACE, INNER ELBOWS, AND UPPER CHEST AND THEN WENT TO THE PATIENT'S RIGHT SHOULDER, STOMACH, AND INNER EAR CANAL AND BECAME A SYSTEMIC RASH CAUSING BOWEL ISSUES. THE ORIGINAL PROCEDURE FOR THE RIGHT SHOULDER ARTHROSCOPIC STEMLESS REPLACEMENT WAS ON (B)(6) 2022. THE ORIGINAL AND REVISION PROCEDURES WERE PERFORMED WITH THE SAME SURGEON IN THE SAME FACILITY. THE PATIENT THEN INQUIRED ABOUT THE MATERIAL COMPOSITION OF THE AR-9345-17T ARTHREX ECLIPSE¿ TITANIUM HUMERAL HEAD 45/17 IMPLANTED IN THE REVISION SURGERY. THE PATIENT WOULD LIKE TO KNOW IF THE TITANIUM HAS NICKEL OR OTHER METALS. THE PATIENT HAS A NICKEL ALLERGY AND IS CONCERNED ABOUT HAVING ANOTHER REACTION LIKE BEFORE.

  Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction

  MAUDE report 21102517 ↗
• InjuryAug 9, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A LOOSENING OF THE PEGGED GLENOID LED TO AN EXPLANTATION OF THE ANATOMIC ECLIPSE PROSTHESIS AND THE PEGGED GLENOID. NO FURTHER INFORMATION WAS PROVIDED. UPDATE AVOE (B)(6) 2023: IT WAS CONFIRMED THAT THE INITIAL SURGERY TOOK PLACE IN 2015 IN THE PRIVATKLINIK BETHANIEN, 8044 ZÜRICH. AFTER THE ECLIPSE AND THE PEGGED GLENOID WERE EXPLANTED, THESE DEVICES WERE REPLACED WITH DEVICES FROM ANOTHER MANUFACTURER.

  Patient problems: Failure of Implant

  MAUDE report 17486646 ↗
• MalfunctionMar 21, 2022Degraded; Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS NECESSARY DUE TO A PROGRESSIVE POLYETHYLENE DEGRADATION WITH METALLOSIS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Metal Related Pathology

  MAUDE report 13839585 ↗
• InjuryOct 23, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS DISCOVERED DURING SOCIAL SAFEGUARD REVIEW THAT THE FOLLOWING INCIDENT WAS MENTIONED IN AN ARTHREX CHATTER COMMUNITY: ON (B)(6) 2019 A (B)(6) YEAR OLD PATIENT UNDERWENT A REVISION PROCEDURE WHERE AN ARTHREX ECLIPSE AR-9345-17 (LOT 1295172500) WAS EXPLANTED. THE PATIENT HAD A LONG SURGICAL HISTORY INVOLVING THIS SHOULDER. INCLUDING AN OPEN GLENOHUMERAL OPERATION THAT REQUIRED HIS SUBSCAPULARIS BEING TAKEN DOWN. THE SUBSCAP REPAIR DID NOT INVOLVE ARTHREX PRODUCTS AND WAS REPORTED TO HAVE FAILED. THE ARTHREX ECLIPSE DEVICE HAD BEEN IMPLANTED DURING A 2018 PROCEDURE WHICH WAS PERFORMED IN KUWAIT. THERE IS NO ADDITIONAL INFORMATION AVAILABLE WITH REGARD TO THE ORIGINAL ARTHREX IMPLANT PROCEDURE. DURING THE (B)(6) 2019 PROCEDURE THE ARTHREX ECLIPSE DEVICE WAS FOUND TO BE HAVE A SOLID FIXATION IN THE PATIENT BONE. THE DEVICE WAS ABLE TO BE EXPLANTED WITH ONLY THE MINIMAL BONE LOSS EQUAL TO THE SPACE OF THE 18MM CAGE SCREW. DURING THE PROCEDURE THE CAGE SCREW, REUNION AND GLENOID WERE ALSO REMOVED HOWEVER THERE IS NO INFORMATION AVAILABLE WITH REGARD TO THE PART NUMBERS OF THESE DEVICES. THE DEVICES WILL NOT BE RETURNING TO ARTHREX FOR EVALUATION BECAUSE THEY WERE REPORTED TO HAVE BE

  Patient problems: Osteolysis; Tissue Damage

  MAUDE report 9225661 ↗
• InjuryJun 28, 2017Failure To Adhere Or Bond; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT RECEIVED AN ECLIPSE IMPLANT INTO THE LEFT SHOULDER WITH THE FOLLOWING DEVICES USED DURING PROCEDURE: AR-9345-17, LOT 1611019 ((B)(4)); AR-9300-45CPC, LOT 150083212((B)(4)); AR-9301-02, LOT 150073614 ((B)(4)); AND AR-1928SF-3, LOT 10020391 ((B)(4)); ALONG WITH A NON ARTHREX GLENOID. THE IMPLANTS GOT DISLOCATED DUE TO A TENDON THAT DID NOT ADHERE IT. THE DECISION WAS MADE TO REVISE IT WITH A REVERSE IMPLANT IN 2017. DURING THE REVISION SURGERY WHEN THE SHOULDER WAS OPENED THE SURGEON FOUND PUS AND THE ECLIPSE IMPLANTS WERE LOOSE IN THE JOINT. PATHOLOGICAL INVESTIGATION DID NOT FIND ANY LAB CULTURE BUT A FOREIGN BODY REACTION /ALLERGIC REACTION WAS DIAGNOSED. ADDITIONAL INFORMATION RECEIVED ON 13 JUN 2017: INFORMATION RECEIVED THAT THE COMPLAINT DEVICES WILL NOT BE RETURNED AS THEY WERE DISCARDED AT THE FACILITY. DATE OF THE INITIAL SURGERY WAS ON (B)(6) 2017, DATE OF SECOND SURGERY/REVISION WAS ON (B)(6) 2017.

  Patient problems: Foreign Body Reaction; Purulent Discharge; Reaction

  MAUDE report 6672682 ↗