Arthrex® AR-9100-08PRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867057081), received between Dec 7, 2020 and May 1, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Defective Device” (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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 1, 2023Defective Device; Defective Device

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9100-08P UNIVERS II HUMERAL STEM 8MM HAD AN INCLINATION SCREW LOCKED IN POSITION WHEN OPENED. THE CASE WAS COMPLETED SUCCESSFULLY BY USING A BIGGER SIZE (9) PRIMARY STEM. THIS WAS DISCOVERED DURING A REVERSE TOTAL SHOULDER PROCEDURE, WITH NO PATIENT HARM. ADDITIONAL INFORMATION RECEIVED ON 4/05/2023: THE LOCKED INCLINATION SCREW WAS DISCOVERED DURING IMPLANTATION. THE GLENOID FRACTURE WAS CAUSED BY SCREWING THE GLENOSPHERE TO THE BASE PLATE. ADDITIONAL INFORMATION RECEIVED ON 4/5/2023: THE FAULTY AR-9100-08P ARTHREX UNIVERS II HUMERAL STEM 8MM WAS DISCOVERED PRIOR TO IMPLANTATION. THE SURGEON HAD ORIGINALLY PLANNED FOR AN RSA PROCEDURE BUT DUE TO A FRACTURE OF THE GLENOID WHILE SCREWING IN THE AR-9560-24-2 BASEPLATE AND AN AR-9564-2433-LAT GLENOSPHERE. IT WAS NOT CAUGHT UNTIL THE GLENOSPHERE WAS INSERTED AND THE ENTIRE BASEPLATE ROTATED AND SHIFTED. THE SURGEON PROCEEDED BY REMOVING THE GLENOSPHERE WITH A REMOVAL DEVICE AND THE BASEPLATE WAS PULLED OUT BY HAND. THE CASE WAS COMPLETED USING AN AR-9100-09PC ARTHREX UNIVERS II STEM, SIZE 9. ADDITIONAL INFORMATION RECEIVED ON 4/6/2023; THE PROCEDURE WAS DELA

  Patient problems: Bone Fracture(s)

  MAUDE report 16844966 ↗
• InjuryDec 7, 2020Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT THAT SHE UNDERWENT TOTAL JOINT REPLACEMENT IN HER SHOULDERS IN 2009 AND 2010. PATIENT IS CURRENTLY UNDER CARE FOR SYSTEMIC SCLEROSIS AND HAS BLOODWORK DONE EVERY 6 MONTHS. THE COBALT/CHROMIUM LEVEL IN HER BLOOD IS INCREASING. AT TIME OF INITIAL REPORT PART NUMBERS WERE NOT PROVIDED BUT HAVE BEEN REQUESTED. ADDITIONAL INFORMATION OBTAINED 11/17/20: THE PATIENT UNDERWENT RIGHT SHOULDER SURGERY (B)(6) 2009. PATIENT ALSO HAD LEFT SHOULDER SURGERY (B)(6) 2010 APPROXIMATELY ONE YEAR LATER THE PATIENT HAD A REVISION SURGERY ON THE LEFT SHOULDER BOTH THE (B)(6) 2010 SURGERY AND THE REVISION OF THAT SURGERY WERE DONE BY THE SAME SURGEON/FACILITY AS THE 2009 PROCEDURE. PATIENT IS UNSURE WHAT THE REVISION SURGERY ACTUALLY ENTAILED. PATIENT IS SEEING A RHEUMATOLOGIST FOR HER SYSTEMIC SCLEROSIS AND IT HAS BEEN DISCOVERED THAT SHE HAS COB ALT IN HER BLOOD. PATIENT WAS REFERRED TO HER PRIOR HIP REPLACEMENT SURGEON (DIFFERENT THAN SHOULDER SURGEON). MRI'S WEE PERFORMED AND SHOWED NO COMPROMISE. PATIENT BELIEVES THIS WAS PERFORMED APPROXIMATELY (B)(6) 2019. AT THIS TIME THEY DO NOT BELIEVE THAT ANY OF HER CURRENT HEALTH ISSUE ARE DUE TO THE COBALT ISSUE. THE CONCERN I

  Patient problems: Toxicity

  MAUDE report 10962178 ↗