Arthrex® AR-9301-03Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00888867059948), received between May 10, 2021 and Mar 31, 2026 — classified as 10 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (5 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryMar 31, 2026Patient Device Interaction Problem

  ON 10-MAR-2026, A CLINDEX NOTIFICATION WAS RECEIVED VIA EMAIL INDICATING THAT INFORMATION HAD BEEN OBTAINED FROM A CLINICAL STUDY (SHOULDER ARTHROPLASTY REGISTRY, IIRR 00608). THE SUBJECT¿S INITIAL SHOULDER ARTHROPLASTY PROCEDURE HAD BEEN PERFORMED ON (B)(6) 2026 USING THE ECLIPSE IMPLANT SYSTEM. ACCORDING TO THE REPORT, THE SUBJECT HAD BEEN SEEN IN THE OFFICE TWO WEEKS AFTER THE TOTAL SHOULDER ARTHROPLASTY. ON PHYSICAL EXAMINATION, HUMERAL SUBLUXATION WAS PALPATED ANTERIORLY, WHICH WAS REDUCIBLE INTO THE GLENOHUMERAL JOINT. X RAYS OBTAINED DURING THE VISIT DEMONSTRATED ANTERIOR INFERIOR SUBLUXATION OF THE HUMERUS. THE SUBJECT DID NOT REPORT ANY TRAUMA PRIOR TO THE DISCOVERY OF THE SUBLUXATION. NON-OPERATIVE MANAGEMENT OPTIONS, REVISION SUBSCAPULARIS REPAIR, AND CONVERSION TO REVERSE SHOULDER ARTHROPLASTY (RSA) WERE DISCUSSED WITH THE SUBJECT. THE SUBJECT ELECTED TO PROCEED WITH SURGICAL MANAGEMENT FOR THE SUBSCAPULARIS FAILURE. ACCORDING TO THE REPORT, THE EVENT WAS ASSESSED AS PROBABLY RELATED TO THE DEVICES. ON 23 MAR 2026, AN UPDATED CLINDEX NOTIFICATION WAS RECEIVED VIA EMAIL, INDICATING THAT THE REPORTED EVENT WAS DETERMINED TO BE UNRELATED TO THE SUBJECT DEVICES AND THAT THE

  Patient problems: Subluxation

  MAUDE report 24741064 ↗
• InjuryNov 17, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 DUE TO LOOSENING OF THE GLENOID COMPONENT AND PERSISTENT PAIN REPORTED BY THE PATIENT. INTRAOPERATIVELY, PRONOUNCED METALLOSIS WAS DETECTED. THE POLYETHYLENE (PE) INLAY EXHIBITED SIGNIFICANT EROSION, AND THE UNIVERSAL BASEPLATE WAS FOUND TO BE PARTIALLY ERODED AS WELL. ALL COMPONENTS AND ASSOCIATED FRAGMENTS WERE REMOVED. SUBSEQUENTLY, A REVERSE SHOULDER PROSTHESIS (UNIVERS REVERS COMBINED WITH THE MODULAR GLENOID SYSTEM) WAS IMPLANTED.

  Patient problems: Metal Related Pathology

  MAUDE report 23569530 ↗
• InjuryJun 6, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 4/15/2025, 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 5/14/2025: 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 22161745 ↗
• 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 21586167 ↗
• InjurySep 19, 2024Break; Break

  UPDATE (B)(6) 24-SEP-2024: FURTHER INFORMATION WAS PROVIDED THAT THE CUSTOMER HAS REMOVED THE GLENOID ARTHROSCOPIC. IT WAS THEN FURTHER REPORTED THAT DUE TO AN OMARTHROSE AN ADDITIONAL SURGERY WAS PERFORMED AND AN INVERSE SHOULDER-TEP WAS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 20256834 ↗
• InjuryAug 12, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON PICTURES IT WAS FOUND THAT AFTER AN IMPLANTATION IN (B)(6) 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 (B)(6) IN (B)(6) 2007. 3 YEARS AGO, THE PROSTHESIS STARTED TO MAKING NOISES IN SPECIFIC MOVEMENTS. (B)(6) 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 19966876 ↗
• MalfunctionFeb 8, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON JULY 11, 2022, A NOTIFICATION WAS RECEIVED INDICATING THAT A PATIENT, LISTED ON THE SHOULDER ARTHROPLASTY REGISTRY, IS EXPERIENCING WORSENING PAIN. AN X-RAY SHOWS A DISLODGED GLENOID COMPONENT. SURGEON HAS SCHEDULED THE PATIENT FOR A REVISION SURGERY TO AN RSA ON (B)(6) 2022. ORIGINAL SURGERY TOOK PLACE ON (B)(6) 2020. ADDITIONAL INFORMATION RECEIVED ON 7/12/2022: DURING SURGERY ON (B)(6) 2020, A TOTAL OF 4 ARTHREX DEVICES WERE IMPLANTED. AN AR-9301-03 ECLIPSE CAGE SCREW LARGE, LOT NUMBER 19.00501, AN AR-9301-43CPC ECLIPSE TRUNION, LOT NUMBER 18-01245, AN AR-9343-16 ECLIPSE HUMERAL HEAD, LOT NUMBER 1917001, AND AN AR-9106-01 UNIVERS VAULTLOCK GLENOID. AS OF NOW, NOTHING HAS SHOWN TO BE BROKEN INSIDE THE PATIENT BUT THERE'S AS DISLODGMENT OF GLENOID PROSTHESIS. ADDITIONAL INFORMATION RECEIVED ON 7/25/2022: ACCORDING TO FACILITY REPRESENTATIVE, PATIENT EXPERIENCE CARDIAC EVENTS DURING THE PRE-OP AREA AND REVISION SURGERY DID NOT TAKE PLACE. AT THIS TIME, IT IS UNKNOWN IF PATIENT WILL UNDERGO REVISION SURGERY. ADDITIONAL INFORMATION RECEIVED ON 12/30/2022: THE REVISION SURGERY THAT WAS TO TAKE PLACE ON (B)(6) 2022, WAS CANCELLED DUE TO CARDIAC CO-MORBIDITIES. NO FURTHER INFORMATION

  Patient problems: Pain

  MAUDE report 18666666 ↗
• 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 17199222 ↗
• InjuryFeb 9, 2023Positioning Failure; Inadequacy of Device Shape and/or Size; Use of Device Problem; Positioning Failure

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT WHILE USING AN AR-9301-03 ARTHREX ECLIPSE CAGE SCREW LARGE, AN AR-9400-SBK ECLIPSE SPEEDSCAP IMPLANT SYSTEM AND AN AR-9301-51CPC ECLIPSE TRUNION, DURING THE FINAL STEPS, THE SURGEON DRILLED THE PILOT HOLE INTO THE SCREW AND FIXATION WAS COMPROMISED. SURGEON MOVED TO AN APEX SYSTEM INSTEAD. WHILE USING THE APEX, FIXATION WAS ALSO COMPROMISED WHEN TRAILING THE HEAD, SO SURGEON USED A LARGER SIZE INSTEAD.

  Patient problems: Insufficient Information

  MAUDE report 16341666 ↗
• 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 11912041 ↗
• MalfunctionMay 18, 2021Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PEGGED GLENOID GOT LOOSE AFTER SEVEN YEARS. A REVISION SURGERY WILL BE NECESSARY. UPDATE SWIT 23-DEC-2020: INITIAL SURGERY TOOK PLACE ON (B)(6) 2013. SURGERY REPORT INDICATION: PATIENT HAT PAIN IN THE RIGHT SHOULDER FOR ABOUT THREE TO FOUR YEARS WITH ONLY SOME LIMITED MOVEMENT. THE APRON GRIP IN PARTICULAR IS INCREASINGLY LIMITED. THE EXAMINATIONS INCLUDING AN ARTHRO MRI FROM (B)(6) 2012 REVEALED A PRONOUNCED OMARTHROSIS WITH A SLAP LESION AT A HIGH LEVEL. THE HUMERAL HEAD IS PROGRESSIVELY SUBLUXATING DORSALLY. THE INDICATION FOR SHOULDER ARTHROPLASTY IS CLEAR. REVISION SURGERY TOOK PLACE ON (B)(6) 2020.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 11841617 ↗
• InjuryMay 10, 2021Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN ECLIPSE TOTAL SHOULDER CASE NEEDED A REVISION DUE TO A FAILED RCR. THERE WAS NO REPORT OF AN EVENT THAT CAUSED THE FAILURE. THE CALLER DID NOT KNOW THE ORIGINAL DATE OF SURGERY (STATED ONLY THAT IT WAS 'YEARS AGO'). THE PATIENT IS MALE, (B)(6) YEARS OLD. THE DEVICES FROM THE ORIGINAL CASE WERE REMOVED; THESE WERE REPLACED WITH AR-9502F-39CPC, AR-9501-10P, AR-9503M-03.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11800039 ↗