Arthrex® AR-9106-03Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00888867239333), received between May 14, 2020 and Sep 29, 2026 — classified as 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 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 50938380 ↗
• MalfunctionJan 5, 2026Break

  ON 16-DEC-2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-9106-03 VAULT LOCK GLENOID TRIAL BOTTOM PEG BROKE OFF. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. NO DELAY TO CASE. ALL FRAGMENTS WERE REMOVED AND THE CASE COMPLETED USING ANOTHER GLENOID TRIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23958212 ↗
• 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 22162004 ↗
• InjuryDec 5, 2024Material Fragmentation; Patient Device Interaction Problem; Material Fragmentation; Patient Device Interaction Problem

  ADDITIONAL INFORMATION WAS RECEIVED ON 11/22/2024 VIA EMAIL: THE REACTION WAS LOCALIZED IN THE SHOULDER JOINT, AND NO REVISION HAS BEEN SCHEDULED YET.

  Patient problems: Foreign Body Reaction; Implant Pain

  MAUDE report 20854167 ↗
• MalfunctionNov 27, 2024Defective Component; Defective Component

  ADDITIONAL INFORMATION WAS RECEIVED ON 12/19/2024: ALL FRAGMENTS WERE REMOVED FROM THE PATIENT. THERE WAS A CASE DELAY OF THIRTY MINUTES WHILE WAITING FOR A SECOND IMPLANT. IT IS UNKNOWN IF ADDITIONAL ANESTHESIA WAS ADMINISTERED TO THE PATIENT. THE CASE WAS COMPLETED WITH A NEW IMPLANT WITH NO COMPLICATIONS. NO ADVERSE EFFECTS ON THE PATIENT REPORTED. THIS WAS DISCOVERED DURING A TSA PROCEDURE ON (B)(6) 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20796889 ↗
• MalfunctionOct 4, 2021Break

  IT WAS REPORTED THAT DURING A SHOULDER PROSTHETICS SURGERY TWO DEVICES BROKE INSIDE THE PATIENT. NO BROKEN PARTS REMAINED INSIDE THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12569177 ↗
• MalfunctionJul 6, 2021Break

  IT WAS REPORTED THAT WHEN THE SURGEON WAS APPLYING BONE GRAFT TO THE CENTER PEG OF THE VAULTLOCK GLENOID IMPLANT, THE CENTER PEG BROKE OFF. THE FRAGMENT WAS REMOVED AND THE CASE WAS COMPLETED WITHOUT FURTHER ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12123744 ↗
• InjuryMay 14, 2020Appropriate Device Problem Term/Code Not Available; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA THE SURGICAL OUTCOME SYSTEM THAT A PATIENT HAD PREVIOUS SHOULDER PROCEDURE. THE PATIENT EXPERIENCED LOOSENING OF THE IMPLANT ON THE HUMERAL SIDE THAT WAS UNRELATED TO ANY TRAUMA. THE PATIENT UNDERWENT A REVISION TO A DIFFERENT TYPE OF ARTHROPLASTY. PATIENT IS ONGOING AND IMPROVING. NO FURTHER INFORMATION WAS PROVIDED FROM THE SURGICAL OUTCOME SYSTEM. FURTHER INVESTIGATION IS IN PROCESS. ADDITIONAL INFORMATION OBTAINED 04/14/2020: PATIENT UNDERWENT A RIGHT TOTAL SHOULDER ARTHROPLASTY AND OPEN BICEP STENOSIS PROCEDURE ON (B)(6) 2016. PATIENT BEGAN EXPERIENCING PAIN ISSUES IN (B)(6) 2018. ON (B)(6) 2020 THE SAME SURGEON PERFORMED A REVISION PROCEDURE AT THE SAME FACILITY. THE REVISION PROCEDURE WAS AN OPEN SURGERY, REVISION TO REVERSE REPLACEMENT. EXPLANTED PART NUMBERS ARE NOT YET KNOWN. PATIENT STUDY ID IS (B)(6). ADDITIONAL INFORMATION OBTAINED 04/22/2020: THE FOLLOWING ARE THE IMPLANT PART NUMBERS FROM THE ORIGINAL (B)(6) 2016 PROCEDURE. ALL OF THE DEVICES LISTED WERE EXPLANTED DURING THE REVISION PROCEDURE ON (B)(6) 2020. THE DEVICE DISPOSITION IS UNKNOWN.: AR-9106-03 UNIVERS VAULTLOCK GLENOID (LOT 1027261550), AR-9150-19P UNIVERS II HUMERAL HEAD (LOT 15008491

  Patient problems: Failure of Implant

  MAUDE report 10055580 ↗