Arthrex® AR-9301-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00888867059924), received between Dec 4, 2019 and Jun 16, 2025 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Degraded” (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.

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.

• InjuryJun 16, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A REVISION SURGERY WAS REQUIRED FROM AN ECLIPSE + UNIVERSAL GLENOID TO UNIVERS LAPEL WITH UNIVERSAL GLENOID GLENOSPHERE. THE INITIAL SURGERY WAS PERFORMED ON (B)(6) 2019. THE REVISION SURGERY WAS REQUIRED DUE TO HUMERAL LOOSENING OF THE ECLIPSE PROSTHESIS. ACCORDING TO THE SURGEONS STATEMENT THE IMPLANT WAS ORIGINALLY POORLY INSERTED. DURING THE REVISION, HOWEVER, IT WAS NOTED THAT THE GLENOID PE INSERT OF THE UNIVERSAL GLENOID LOOKED UNUSUAL. THE GLENOID INSERT WAS PROBABLY SUBJECTED TO DECENTRALIZED LOADING DUE TO THE POOR POSITIONING OF THE HUMERAL COMPONENT AND THEREFORE SHOWED UNUSUAL WEAR PATTERNS. HOWEVER, IT WAS ALSO NOTICEABLE THAT A KIND OF LAYER HAD COME LOOSE ON THE GLENOID INSERT ("DELAMINATION"). THE AFFECTED DEVICES AR-9121-02, AR-9347-18, AR-9300-47 AND AR-9301-01 WERE REMOVED AND THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION RECEIVED.

  Patient problems: Failure of Implant

  MAUDE report 22211942 ↗
• MalfunctionJan 13, 2025Positioning Failure; Positioning Failure

  ON 12/16/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9400-SBK ECLIPSE SPEEDSCAP IMPLANT SYSTEM DID NOT GET SUFFICIENT FIXATION WITH THE ECLIPSE TRUNION AND CAGE SCREW. THE CASE WAS COMPLETED USING A LONG STEM. THIS WAS DISCOVERED DURING AN ANATOMIC TOTAL SHOULDER PROCEDURE ON (B)(6)2024. ADDITIONAL INFORMATION RECEIVED ON 12/30/2024: THE PART NUMBERS AR-9301-02 AND CAGE SCREW AND AR-9301-45CPC ARTHREX ECLIPSE TRUNION WERE PROVIDED. ADDITIONALLY, THE SALES REPRESENTATIVE REPORTED THAT ANOTHER AR-9400-SBK ECLIPSE SPEEDSCAP IMPLANT SYSTEM FROM A DIFFERENT LOT NUMBER AND AN AR-9301-01 ARTHREX ECLIPSE CAGE SCREW WAS ATTEMPTED TO BE USED AS WELL BUT STILL COULD NOT GET SUFFICIENT FIXATION. THE CASE WAS COMPLETED USING AN AR-9100-05M UNIVERS APEX OPTIFIT HUMERAL STEM. THE CASE WAS DELAYED BETWEEN THIRTY TO FORTY MINUTES; HOWEVER, ADDITIONAL ANESTHESIA WAS NOT NEEDED.

  Patient problems: Insufficient Information

  MAUDE report 21138163 ↗
• InjuryNov 22, 2022Insufficient Device Problem Information

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9301-01 ECLIPSE CAGE SCREW, AN AR-9301-39CPC ECLIPSE TRUNION, AND AN AR-9339-16 ECLIPSE HUMERAL HEAD WERE IMPLANTED. THE SURGEON DEEMED IT NECESSARY TO EXPLANT THE ECLIPSE TRUNION, CAGE SCREW, AND HUMERAL HEAD, AND UPGRADE TO APEX STEMMED IMPLANT DUE TO BONE QUALITY ISSUES. THIS WAS DISCOVERED DURING AN ANATOMIC TOTAL SHOULDER REPLACEMENT PROCEDURE ON (B)(6) 2022.

  Patient problems: Insufficient Information

  MAUDE report 15842716 ↗
• InjuryMay 9, 2022Degraded

  IT WAS REPORTED THAT ONE YEAR AFTER THE IMPLANTATION OF A RIGHT SHOULDER TOTAL ENDO-PROSTHESIS ECLIPSE ON (B)(6) 2016, POLYETHYLENE DEGRADATION WAS IDENTIFIED POST-OPERATIVELY. THIS RESULTED IN A BONE DEFECT WHICH LED TO A REVISION SURGERY TO CHANGE THE IMPLANT TO AN INVERSE PROSTHESIS.

  Patient problems: Failure of Implant

  MAUDE report 14337441 ↗
• InjuryAug 11, 2021Positioning Problem

  IT WAS REPORTED DURING A TOTAL SHOULDER ARTHROPLASTY, WHEN THE SURGEON WAS GOING TO USE THE ECLIPSE, IT WAS NOT SITTING WELL AND THE SURGEON DIVERTED TO AN UNIVERS HEAD AND APEX STEM. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12306248 ↗
• InjuryJun 3, 2020Adverse Event Without Identified Device or Use Problem

  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: Pain

  MAUDE report 10113948 ↗
• InjuryMar 10, 2020Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED DURING AN ECLIPSE TOTAL SHOULDER PROCEDURE, THE SURGEON SAWED THE HUMERAL HEAD OFF, PUT CAP ON THE HUMERUS AND COMPLETED THE GLENOID WITHOUT ISSUE. WHEN THE SURGEON CAME BACK TO COMPLETE THE HUMERUS, THE BONE QUALITY WAS VERY POOR AND THE AR-9301-01 (LOT: 18.01100) CAGE SCREW WOULD NOT HOLD. UPON PULLING OUT THE CAGE SCREW IT WAS NOTED THAT THE SCREW WAS FULL OF BONE. THE SURGEON THEN SWITCHED TO A LONGER CAGE SCREW (AR-9301-02 / LOT: 18.01106) TO GET A DEEPER BITE, BUT IT PULLED OUT AS WELL. THE REP STATED AT THIS POINT THE SURGEON WAS VERY UPSET, AND DECIDED TO REMOVE ALL IMPLANTED PRODUCT AND SWITCH TO AN MGS REVERSE TOTAL SHOULDER. THE REP REPORTED NO ADDITIONAL INCISIONS WERE NEEDED, JUST A DIFFERENT IMPLANT SYSTEM WAS USED TO COMPLETE THE PROCEDURE WITHOUT FURTHER ISSUE. THE FOLLOWING PRODUCTS WERE FIRST IMPLANTED, AND THEN IMMEDIATELY EXPLANTED; AR-9301-01 / LOT: 18.01100 - ECLIPSE SMALL CAGE SCREW, AR-9301-02 / LOT: 18.01106 - ECLIPSE MEDIUM CAGE SCREW, AR-9301-41CPC / LOT: 18.01145 - ECLIPSE TRUNNION SIZE 41, AR-9121-01 / LOT: 170139713 - GLENOID INLAY SMALL, AR-9165-25NL / LOT: 10221985 - CENTRAL NON-LOCKING SCREW, AR-9145-36 / LOT: 18.00586 - PERIPHERAL L

  Patient problems: No Code Available

  MAUDE report 9810633 ↗
• InjuryDec 16, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT (FEMALE (B)(6) ), HAD AN ECLIPSE TOTAL SHOULDER ON (B)(6) 2016. DUE TO A SUBSEQUENT TORN ROTATOR CUFF, SHE NEEDED TO HAVE A REVERSE TOTAL SHOULDER ON (B)(6) 2019. REPORTER STATED THAT THE TORN ROTATOR CUFF WAS NOT DUE TO PRODUCT MALFUNCTION. REMOVED FROM THE PATIENT WAS AR-9341-16, AR-9300-41CPC AND AR-9301-01.

  Patient problems: No Code Available

  MAUDE report 9473783 ↗
• InjuryDec 4, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT HAD AN ECLIPSE SURGERY ON THE (B)(6) 2016. FOR A WHILE EVERYTHING WAS FINE AND NO COMPLAINTS, BUT THEN ALL OF A SUDDEN SHE FELT PAIN. THE SURGEON DECIDED ON A REVISION SURGERY WHERE THE FOLLOWING ARTHREX DEVICES WERE EXPLANTED: AR-9105-01, AR-9341-16 (1295154707), AR-9300-41CPC (14.641), AR-9301-01 (13.225) A NEW PROSTHESIS FROM ANOTHER MANUFACTURER WAS IMPLANTED. NO FURTHER INFORMATION RECEIVED.

  Patient problems: Pain

  MAUDE report 9409966 ↗