Arthrex® AR-9106-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00888867239326), received between Dec 13, 2018 and Mar 12, 2025 — classified as 11 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 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 21586156 ↗
• MalfunctionMay 6, 2024Use of Device Problem; Use of Device Problem

  ON 6/20/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9106-02 UNIVERS VAULTLOCK GLENOID DID NOT FULLY SEAT. THE HUMERAL HEAD COMPONENT WAS REMOVED WITH THE EXTRACTION TOOL. THE CAGE SCREW AND TRUNION WERE ALSO UNSCREWED AND REMOVED. THE 3 INFERIOR 4MM GLENOID HOLES WERE RE-DRILLED, BOTH GLENOID BROACHES WERE USED, A TRIAL COMPONENT WAS PLACED AND REMOVED AND A NEW VAULTLOCK GLENOID INSERTED. AUTOLOGOUS BONE FROM THE HUMERAL HEAD WAS PLACED IN THE AREA WHERE THE CAGE SCREW WAS REMOVED AND COMPACTED. THE TRUNION AND CAGE SCREW WERE INSERTED WITH EXCELLENT PURCHASE AND THE SHOULDER WAS REDUCED WITHOUT COMPLICATIONS. THIS WAS DISCOVERED DURING AN ECLIPSE TOTAL SHOULDER ARTHROPLASTY ON (B)(6) 2022. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19247159 ↗
• MalfunctionOct 24, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-9106-02 UNIVERS VAULTLOCK GLENOID, MEDIUM, HAD AN ISSUE BEFORE USE IN AN ANATOMIC STIMULUS TOTAL SHOULDER PROCEDURE ON (B)(6) 2023. WHEN THE SURGEON OPENED THE DEVICE ON THE STERILE FIELD, THERE WAS A HOLE NOTICED IN THE STERILE PACKAGING. ANOTHER AR-9106-02 UNIVERS VAULTLOCK GLENOID, MEDIUM, WITH A DIFFERENT, UNKNOWN LOT NUMBER, WAS OPENED AND USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH NO PATIENT HARM. THERE WAS A CASE DELAY OF 2 MINUTES, NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THE DEVICE WAS DISCARDED, AND NO PICTURES WERE TAKEN. NO CASE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17996653 ↗
• InjuryJun 6, 2022Appropriate Device Problem Term/Code Not Available

  ON 5/17/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT PATIENT UNDERWENT A SHOULDER ARTHROPLASTY PROCEDURE ON (B)(6) 2020. IN (B)(6) 2021, PATIENT COMPLAINED OF PAIN. ON (B)(6) 2022, PATIENT WAS POSITIVE FOR A C. ACNES INFECTION AND UNDERWENT REVISION SURGERY ON (B)(6) 2022. DURING THE REVISION ARTHROPLASTY SURGERY, AN AR-9106-02 ARTHREX UNIVERS VAULTLOCK GLENOID, AN AR-9100-10S UNIVERS APEX HUMERAL STEM, AND AN AR-9148-19P ARTHREX UNIVERS II 3D HUMERAL HEAD WERE EXPLANTED. CASE WAS COMPLETED BY IMPLANTING AN ANTIBIOTIC CEMENT SPACER. THE ORIGINAL SHOULDER ARTHROPLASTY PROCEDURE, WAS PERFORMED AT FOX VALLEY ORTHOPEDIC ASSOCIATES SURGERY CENTER BY A DIFFERENT SURGEON. ADDITIONAL INFORMATION RECEIVED ON 5/18/2022: ALL DEVICES THAT WERE IMPLANTED ON (B)(6) 2020 WERE EXPLANTED DURING REVISION SURGERY ON (B)(6) 2022. AFTER PATIENT COMPLAINT OF PAIN IN (B)(6) 2021, PATIENT WAS MONITORED AND REVISION SURGERY WAS SCHEDULE. DUE TO OTHER NON-ORTHOPEDIC REASONS, REVISION SURGERY WAS DELAYED UNTIL (B)(6) 2022. OTHER THAN THE ANTIBIOTIC CEMENT SPACER, NO NEW ARTHREX DEVICES WERE IMPLANTED DURING REVISION SURGERY.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 14601917 ↗
• InjuryMay 10, 2021Therapeutic or Diagnostic Output Failure

  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, 64 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: Failure of Implant

  MAUDE report 11799774 ↗
• InjuryApr 7, 2021Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED A PATIENT HAD A REVISION SURGERY. THE ORIGINAL SURGERY DATE WAS (B)(6) 2019. THE PATIENT FELL ON (B)(6) 2020 AND SUFFERED FROM A ROTATOR CUFF TEAR. THIS WAS THE PURPOSE OF THE REVISION. THE FOLLOWING PARTS WERE REMOVED AR-9100-06S, AR-9146-18P AND AR-9106-02. THE TOTAL SHOULDER REPLACEMENT WAS REMOVED AND REPLACED TODAY. MALE PATIENT (B)(6) YEARS OF AGE. THE REVISION CASE WAS COMPLETED AND THE PATIENT IS NOW FINE TO DATE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Fall

  MAUDE report 11627267 ↗
• MalfunctionFeb 22, 2021Break

  IT WAS REPORTED THAT THE CENTRAL PEG BROKE OFF THE AR-9106-02 WHEN THE SURGEON WAS PUTTING THE BONE GRAFT ON THE PEG. ANOTHER AR-9106-02 WAS USED TO COMPLETE THE TOTAL SHOULDER CASE.

  Patient problems: Insufficient Information

  MAUDE report 11358148 ↗
• InjuryNov 16, 2020Material Protrusion/Extrusion

  IT WAS REPORTED THAT DURING AN APEX SURGERY WITH THE VAULTLOCK THE DEVICE PROTRUDED. IT WAS STATED THAT THE SURGEON MEASURED THE PEGS OF THE VAULT LOCK AND THE DRILL BIT. THE SURGEON MEASURED 20 MM OF THE DRILL BIT AND 16MM OF THE CENTRAL PEG. IT WAS ALSO REPORTED THAT THE CEMENT IMPACTOR WAS TOO LONG. THE SURGEON HAD TO FILL THE HOLES WITH A BONE GRAFT WHICH LEAD TO A PROLONGED SURGERY. UPDATE 05-NOV-2020: FURTHER INFORMATION ABOUT THE PROCEDURE WERE PROVIDED. THE SURGEON WAS REAMING THE GLENOID BY HAND USING THE NAUTILUS REAMER AND THERE WAS NO AGGRESSIVE REAMING INCORPORATED. WHEN DRILLING THE SUPERIOR PEG THE SURGEON PERFORATED THE BI-CORTICAL BONE. HE FIXED THE SITUATION BY USING BONE CHIPS FROM THE RESECTED HUMERAL HEAD. IT WAS FURTHER REPORTED THAT THE SURGEON HAS NOT USED THE CEMENT PRESSURIZER AR-9235 ACCORDING TO THE SURGICAL TECHNIQUE BUT THE PUNCHER AR-9233 INSTEAD SINCE HE BELIEVES THAT THE PRESSURIZER HAS TO LONG PEGS. THE SURGERY WAS EXTENDED BY 10-15 MINUTES TO FILL THE CAUSED HOLES.

  Patient problems: Perforation

  MAUDE report 10843380 ↗
• InjurySep 2, 2020Tear, Rip or Hole in Device Packaging; Appropriate Device Problem Term/Code Not Available

  IT WAS INITIALLY REPORTED VIA THE SURGICAL OUTCOME ALERT SYSTEM THAT A POSSIBLE REVISION MAY HAVE TAKEN PLACE WITH STUDY PATIENT (B)(6). FURTHER INVESTIGATION HAS NOW CONFIRMED THE FOLLOWING INFORMATION: THE STUDY PATIENT HAD A TOTAL SHOULDER ARTHROPLASTY (B)(6) 2017. DUE TO A COMPLETE TEAR OF THE RIGHT ROTATOR CUFF AND SUBSCAPULARIS INSUFFICIENCY THE PATIENT UNDERWENT A REVISION SURGERY (B)(6) 2018 AT THE SAME FACILITY BY THE SAME SURGEON. DURING THE REVISION SURGERY THE FOLLOWING ARTHREX PRODUCTS WERE EXPLANTED: HUMERAL STEM: AR-9100-06S, GLENOID: AR-9106-02, HUMERAL HEAD: AR-9150-19P. TO COMPLETE THE REVISION SURGERY THE SURGEON USED AND ANTIBIOTIC WASH AFTER REMOVAL OF THE IMPLANTS AND A BONE ALLOGRAFT WAS USED ON THE GLENOID. HUMERAL CANAL WAS REAMED AND BROACHED IN 30 DEGREES OF RETROVERSION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10483869 ↗
• InjurySep 2, 2020Device Dislodged or Dislocated

  IT WAS INITIALLY REPORTED VIA THE SURGICAL OUTCOME ALERT SYSTEM THAT A POSSIBLE REVISION MAY HAVE TAKEN PLACE WITH STUDY PATIENT (B)(6). FURTHER INVESTIGATION HAS NOW CONFIRMED THE FOLLOWING INFORMATION: THE STUDY PATIENT HAD A TOTAL SHOULDER ARTHROPLASTY (B)(6) 2018. DUE TO A ROTATOR CUFF/SUBLUXATION, DEFICIENT SUPRASPINATUS AND SUBSCAPULARIS THE PATIENT UNDERWENT A REVISION SURGERY (B)(6) 2018 AT THE SAME FACILITY BY THE SAME SURGEON. DURING THE REVISION SURGERY THE FOLLOWING ARTHREX PRODUCTS WERE EXPLANTED: GLENOID: AR-9106-02. HUMERAL STEM: AR-9100-09S. HUMERAL HEAD: AR-9144-19P. TO COMPLETE THE REVISION SURGERY THE SURGEON USED AND ANTIBIOTIC WASH AFTER REMOVAL OF THE IMPLANTS A BONE ALLOGRAFT WAS USED ON THE GLENOID. HUMERAL CANAL WAS REAMED AND BROACHED IN 30 DEGREES OF RETROVERSION.

  Patient problems: No Code Available

  MAUDE report 10483737 ↗
• InjuryJul 15, 2020Break

  IT WAS REPORTED THAT DURING A TSA CONVERSION TO AN RTSA, UPON TRYING TO REMOVE THE TSA UNIVERS APEX STEM, THE SLAP HAMMER NUBBIN BROKE OFF IN THE EXTRACTION TOOL LEAVING US WITH A BROKEN SLAP HAMMER. THIS RESULTED IN A DIFFICULT TIME TRYING TO REMOVE THE STEM ADDING AT LEAST 30 MINUTES TO THE CASE. NO ADDITIONAL INCISIONS WERE MADE. SURGEON USED SAME DELTOID/PECTORAL APPROACH FOR TOTAL SHOULDER ARTHROPLASTY PROCEDURE. THEY WERE UNABLE TO PERFORM A NORMAL REMOVAL TECHNIQUE SO THEY USED A TPS BURR TO HELP FACILITATE THE REMOVAL OF THE APEX STEM. NO ADDITIONAL ANESTHESIA WAS NEEDED. PRODUCT AR-9202-14, LOT 250150205, WILL BE RETURNED FOR EVALUATION. THE ORIGINAL TSA PROCEDURE TOOK PLACE (B)(6) 2020 DURING WHICH THE FOLLOWING DEVICES HAD BEEN IMPLANTED: AR-9106-02, UNIVERS VAULTLOCK GLENOID, LOT 1027261917. AR-9100-08S, UNIVERS APEX HUMERAL STEM, LOT 10321781. AR-9150-19P, USP II HUMERAL HEAD, LOT 10291252. THE ORIGINAL TSA AND RTSA WERE PREFORMED BY THE SAME SURGEON AT THE SAME FACILITY. CONVERSION PROCEDURE WAS BEING PERFORMED DUE TO A FAILED ROTATOR CUFF. ALL ORIGINAL IMPLANTS WERE EXPLANTED DURING THE PROCEDURE.

  Patient problems: No Code Available

  MAUDE report 10279151 ↗
• InjuryNov 21, 2019Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THROUGH THE SURGICAL OUTCOME SYSTEM THAT THE PATIENT HAD COMPLICATIONS RELATED TO MOTION LOSS. ADDITIONAL INFORMATION WAS OBTAINED THAT THE PATIENT HAD AN ARTHREX APEX UNIVERS TOTAL SHOULDER SYSTEM IMPLANTED DURING A 6/13/2018 PROCEDURE. THE FOLLOWING DEVICES WERE IMPLANTED DURING THE (B)(6) 2018 PROCEDURE: UNIVERS APEX HUMERAL STEM AR-9100-08S (LOT 10070616), UNIVERS II HUMERAL HEAD AR-9146-18P (LOT 10129357), UNIVERS VAULTLOCK GLENOID MEDIUM AR-9106-02 (LOT 1027261721) AND FIBERTAPE TENDON COMPRESSION BRIDGE KIT WITH JUMPSTART DRESSING AR-7297 (LOT 10197428). DURING PATIENT'S (B)(6) 2019 FOLLOW UP WITH SURGEON IT WAS NOTED THAT THE PATIENT HAD A LACK OF HEALING OF HER SUBSCAPULARIS AND HAS BEEN SCHEDULED FOR REVISION SURGERY ON (B)(6) 2019. SURGEON HAS STATED THAT THE PATIENT HAD AN ANATOMIC ARTHROPLASTY WITH FAILURE OF SUBSCAPULARIS HEALING. WHICH WAS NOT ARTHREX DEVICE RELATED. A FOLLOW UP WILL BE DONE AFTER THE REVISION TAKES PLACES TO CONFIRM IF ANY ARTHREX PRODUCTS ARE EXPLANTED. ADDITIONAL INFO OBTAINED 10/2/19: THE FOLLOWING PARTS WERE IMPLANTED DURING THE (B)(6) 2019 PROCEDURE: AR-9106-02, UNIVERS VAULTLOCK GLENOID MEDIUM, LOT 1027261721, AR-9100-08S, UNIV

  Patient problems: Impaired Healing

  MAUDE report 9353206 ↗
• InjuryJan 8, 2019Loose or Intermittent Connection

  IT WAS REPORTED THAT THE PATIENT NEEDED A REVISION FROM A TOTAL SHOULDER TO A REVERSE SHOULDER DUE TO PAIN. AT THE REVISION, THE GLENOID WAS FOUND TO BE LOOSE. REMOVED FROM THE PATIENT WAS AN AR-9100-06S, AR-9106-02, AR-9150-19P AND AR-7298.

  Patient problems: Pain

  MAUDE report 8226794 ↗
• InjuryDec 13, 2018Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT REQUIRED A REVISION FROM AN APEX TOTAL SHOULDER THAT HE HAD IN (B)(6) 2017. THE REVISION WAS NEEDED DUE TO A TORN SUBSCAPULAR. THE ORIGINAL DEVICES WERE REMOVED AND REPLACED WITH AR-9560-24-2 AND AR-9561-30S. UPDATED 11/29/2018: PARTS/LOT PROVIDED BY THE SALES REP. ORIGINAL PROCEDURE SURGEON WAS DIFFERENT THAN THE REVISION SURGEON. BOTH PROCEDURES WERE PERFORMED AT THE SAME FACILITY. EXPLANTED DEVICES WERE AS FOLLOWS: AR-9100-06S UNIVERS APEX HUMERAL STEM, LOT 10064881; AR-9106-02 UNIVERS VAULTLOCK GLENOID, LOT 1027261621; AR-7298 UNIVERS SPEX SUTURE KIT, LOT 10129987; AR-9150-19P USP II HUMERAL HEAD, LOT 160084018.

  Patient problems: No Information

  MAUDE report 8160807 ↗