Arthrex® AR-9349-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00888867060067), received between Mar 24, 2017 and Sep 29, 2026 — classified as 6 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Patient Device Interaction Problem

  Patient problems: Device Overstimulation of Tissue

  MAUDE report 50938381 ↗
• MalfunctionDec 31, 2025Positioning Failure; Positioning Failure

  ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9349-18 ARTHREX ECLIPSE HUMERAL HEAD WAS NOT ENGAGING PROPERLY WITH THE TRUNNION. THE REPORTER CONFIRMED THAT THE CAGE SCREW WAS FULLY SEATED WITHIN THE TRUNNION. THE TEAM ATTEMPTED TO REMOVE AND RE-IMPLANT THE COMPONENT; HOWEVER, THE ECLIPSE HEAD STILL WOULD NOT SEAT CORRECTLY. A NEW ECLIPSE HEAD WAS OPENED AND IMPLANTED WITHOUT ISSUE, ALLOWING THE PROCEDURE TO PROCEED AS PLANNED. THIS WAS DISCOVERED DURING A TOTAL SHOULDER REPLACEMENT PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 16-DEC-2025: THE ISSUE WAS IDENTIFIED DURING USE INSIDE THE PATIENT. NO FRAGMENTS BROKE AS A RESULT OF THE ISSUE. THE PROCEDURE WAS COMPLETED USING A DIFFERENT ECLIPSE HUMERAL HEAD, AR-9349-20, 49/20, WITH THE ORIGINAL TRUNNION. THERE WAS NO SURGICAL DELAY OR ADDITIONAL ANESTHESIA REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23935634 ↗
• MalfunctionDec 31, 2025Positioning Failure; Positioning Failure

  ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9349-18 ARTHREX ECLIPSE HUMERAL HEAD WAS NOT ENGAGING PROPERLY WITH THE TRUNNION. THE REPORTER CONFIRMED THAT THE CAGE SCREW WAS FULLY SEATED WITHIN THE TRUNNION. THE TEAM ATTEMPTED TO REMOVE AND RE-IMPLANT THE COMPONENT; HOWEVER, THE ECLIPSE HEAD STILL WOULD NOT SEAT CORRECTLY. A NEW ECLIPSE HEAD WAS OPENED AND IMPLANTED WITHOUT ISSUE, ALLOWING THE PROCEDURE TO PROCEED AS PLANNED. THIS WAS DISCOVERED DURING A TOTAL SHOULDER REPLACEMENT PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 16-DEC-2025: THE ISSUE WAS IDENTIFIED DURING USE INSIDE THE PATIENT. NO FRAGMENTS BROKE AS A RESULT OF THE ISSUE. THE PROCEDURE WAS COMPLETED USING A DIFFERENT ECLIPSE HUMERAL HEAD, AR-9349-20, 49/20, WITH THE ORIGINAL TRUNNION. THERE WAS NO SURGICAL DELAY OR ADDITIONAL ANESTHESIA REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23935632 ↗
• InjuryDec 30, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PE INLAY AR-9121-02 OF THE UNIVERSAL GLENOID GOT WORN OFF, RESULTING IN METAL ON METAL CONTACT BETWEEN ECLIPSE HUMERAL HEAD AND THE BASEPLATE OF THE UNIVERSAL GLENOID. THIS RESULTED IN METALLOSE AND RELATED PROBLEMS REQUIRING A REVISION SURGERY WITH A CONVERSION TO A REVERSE PROSTEHSIS. DURING THE REVISION SURGERY THE ECLIPSE HUMERAL COMPONENTS AND THE REMAINING PARTS OF THE INLAY WERE REMOVED AND PROPER SEATING OF THE UNIVERSAL GLENOID BASEPLATE WAS CONFIRMED. THEN A GLENOSPHERE WAS INSERTED ONTO THE BASEPLATE AND THE UNIVERS REVERS HUMERAL COMPONENTS WERE IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Metal Related Pathology

  MAUDE report 23927379 ↗
• InjuryAug 12, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON PICTURES IT WAS FOUND THAT AFTER AN IMPLANTATION IN NOVEMBER 2007 THE COATING OF THE PAN IS ABRADED AND A METALLOSIS IS SUSPECTED. NO INFORMATION PROVIDED BY THE CUSTOMER. UPDATE DW 01-AUG-2024: FURTHER INFORMATION WAS PROVIDED THAT THE PROSTHESIS WAS IMPLANTED IN AGATHARIED FROM PROF. BRUNNER IN OCTOBER 2007. 3 YEARS AGO THE PROSTHESIS STARTED TO MAKING NOISES IN SPECIFIC MOVEMENTS. PROF. BRUNNER HAS DIAGNOSED A WEAR OF THE POLY WITH A METALLOSIS AND OSTEOLYSEN. THE SURGEON ADVISED THE PATIENT TO CLARIFY THE EVENT WITH AN ADDITIONAL ARTHROSCOPY.

  Patient problems: Metal Related Pathology

  MAUDE report 19967189 ↗
• MalfunctionMay 1, 2024Fitting Problem; Fitting Problem

  ON 1/6/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9349-18 HUMERAL HEAD DID NOT SEAT PROPERLY IN THE TRUNION. AFTER SEVERAL FAILED ATTEMPTS, SURGEON OPENED ANOTHER IMPLANT AND IT SEATED CORRECTLY. CASE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER ISSUES. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2021. ADDITIONAL INFORMATION RECEIVED 1/6/2022 THIS WAS DISCOVERED DURING A PRIMARY TOTAL SHOULDER PROCEDURE. SURGEON WAS ABLE TO COMPLETE THE PROCEDURE USING AN ECLIPSE STEM, HUMERAL HEAD AND VAULTLOCK GLENOID WITHOUT FURTHER ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19220907 ↗
• InjuryJun 26, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 6/2/2023, IT WAS REPORTED BY A PATIENT THAT AN ARTHREX ECLIPSE STEMLESS HUMERAL IMPLANT AND CONVERTIBLE UNIVERSAL GLENOID PRODUCTS WERE IMPLANTED DURING A SHOULDER REPLACEMENT PROCEDURE ON (B)(6) 2023. THE PATIENT IS EXPERIENCING A POSSIBLE UNSPECIFIED REACTION. NO FURTHER INFORMATION HAS BEEN PROVIDED. ADDITIONAL INFORMATION RECEIVED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 17199332 ↗
• InjuryJul 28, 2020Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL SHOULDER ARTHROPLASTY USING THE ECLIPSE SYSTEM ON (B)(6) 2020. UPON REVIEW OF THE POST OPERATIVE X-RAY, ON POST-OP DAY 1, IT WAS NOTICED THAT THE SHOULDER WAS DISLOCATED. A SECOND X-RAY WAS PERFORMED THE SAME DAY AND IT WAS CONFIRMED THAT THE SHOULDER WAS IN FACT DISLOCATED. THE PATIENT WAS NOT ABLE TO REMEMBER WHEN OR HOW THE SHOULDER MAY HAVE DISLOCATED. A REVISION TSA-HUMERAL HEAD EXCHANGE SURGERY WAS SCHEDULED AND PERFORMED ON (B)(6) 2020 (POST-OP DAY 1). IT WAS NOTED DURING THE REVISION THAT THE SUBSCAPULARIS REPAIR WAS STILL IN TACT BUT HAD TO BE TAKEN DOWN TO GET THE SHOULDER RELOCATED. AFTER THE SHOULDER WAS RELOCATED THE ECLIPSE HUMERAL HEAD, AR-9349-18 (LOT 18.0147) WAS REMOVED AND THE ENTIRE SHOULDER JOINT WAS EVALUATED FOR ANY POSSIBLE PROBLEM. THE SURGEON THEN PROCEEDED TO TRIAL THREE DIFFERENT HUMERAL HEAD SIZES AND SETTLED ON THE MOST STABLE HUMERAL HEAD WHICH WAS AN AR-9349-20 (LOT 1735002). A SPEEDBRIDGE TECHNIQUE WAS PERFORMED TO REPAIR THE SUBSCAPULARIS.

  Patient problems: Joint Dislocation

  MAUDE report 10333402 ↗
• InjuryMar 24, 2017Device Slipped

  IT WAS REPORTED THAT PATIENT HAD ORIGINAL ECLIPSE SURGERY IN 2013. GLENOID AR-9105-03, (LOT 1230011) (CC108390 LINE 186146), SCREW-AR-9301-02, (LOT 1127024) (CC108390 LINE 187579), TRUNION-AR-9300-49CPC, (LOT 1128006) (CC180390 LINE 187581), HUMERAL HEAD- AR-9349-18, (LOT 947018) (CC180390 LINE 187584) WERE IMPLANTED. FOLLOW-UP SERIAL X RAYS SHOWED INCREASING LUCENT LINES AROUND THE PEGGED GLENOID. PATIENT HAD PAIN AND DECISION WAS MADE TO REVISE TO A REVERS PER SURGEON. REVISION TOOK PLACE ON (B)(6) 2017. THE HUMERAL COMPONENT WAS REMOVED WITHOUT ISSUE. SALES REP NOTED THAT THE ECLIPSE PROSTHESIS WAS EXTREMELY WELL FIXED AND THE CAGE SCREW HAD COMPLETE BONE THROUGH GROWTH. THE GLENOID WAS LOOSE AND WAS REMOVED BY HAND WITH PEGS INTACT. CEMENT WAS REMOVED FROM THE GLENOID. AUTOGRAFT WAS TAKEN FROM THE ILIAC CREST TO ADDRESS THE BONE DEFECT IN THE GLENOID. THE ALLOGRAFT WAS PREPARED FOR THE REVERS BASE PLATE IN SITU PRIOR TO HARVESTING THE GRAFT. THE BASEPLATE WAS THEN TRIED TO MATCH THE BONE DEFECT. THE BONE GRAFT AND BASE PLATE WERE IMPLANTED AND FIXATED WITH THE BASEPLATE SCREWS. THE REST OF THE REVERS SURGICAL TECHNIQUE WAS FOLLOWED TO COMPLETE THE CASE. PATIENT WAS A (B)(6) MA

  Patient problems: Pain

  MAUDE report 6431866 ↗