Arthrex® AR-9562-40NLRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867296756), received between Jan 12, 2021 and Nov 19, 2024 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryNov 19, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 10/28/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9564-2442-LAT GLENOSPHERE AND GLENOSPHERE SET SCREW DISENGAGED FROM THE BASEPLATE. THE PATIENT UNDERWENT SURGERY ON (B)(6) 2023 FOR A REVERSE SHOULDER ARTHROPLASTY. POSTOPERATIVELY THE PATIENT EXPERIENCED PAIN AND A CT SCAN REVEALED GLENOSPHERE AND GLENOSPHERE SET SCREW DISENGAGED FROM THE BASEPLATE. ON (B)(6) 2023, THE PATIENT UNDERWENT A REVISION SURGERY IN WHICH A NEW GLENOSPHERE ALONG WITH HUMERAL COMPONENTS WERE IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED ON 11/4/2024: DURING THE REVISION SURGERY, THE AR-9502F-39LCPC SUTURECUP, THE AR-9503-3942-3 HUMERAL INSERT, THE AR-9501-07P HUMERAL STEM, THE AR-9582-20 MODULAR POST, THE AR-9563-28 PERIPHERAL LOCKING SCREW, THE AR-9563-16 PERIPHERAL LOCKING SCREW, THE AR-9563-20 PERIPHERAL LOCKING SCREW, THE AR-9562-40NL PERIPHERAL LOCKING SCREW, THE AR-9580-2010-2S BASEPLATE, AND AR-9564-2442-LAT GLENOSPHERE WAS REMOVED. BOTH PROCEDURES WERE PERFORMED BY THE SAME SURGEON AND AT THE SAME FACILITY.

  Patient problems: Pain

  MAUDE report 20726301 ↗
• InjuryAug 5, 2024Break; Patient Device Interaction Problem; Break; Patient Device Interaction Problem

  ADDITIONAL INFORMATION RECEIVED ON 11/4/2024: ON (B)(6) 2024, THE PATIENT'S IMPLANTS WERE CONVERTED FROM FAILED REVERS TO A HEMIARTHROPLASTY DUE TO THE DISPLACED GLENOID COMPONENTS FROM THE BROKEN SCREWS. AT THIS TIME, IT IS UNKNOWN WHICH ARTHREX PRODUCTS FROM THE ORIGINAL SURGERY ON (B)(6) 2023 WERE EXPLANTED DURING THE REVISION SURGERY ON (B)(6) 2024.

  Patient problems: Pain

  MAUDE report 19907222 ↗
• InjuryMar 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 3/1/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT A SHOULDER ARTHROPLASTY REVISION SURGERY TOOK PLACE ON (B)(6) 2023 DUE TO AN INFECTION. THE SURGEON REMOVED AN AR-9560-28 ARTHREX UNIVERS REVERS MODULAR GLENOID SYSTEM MODULAR BASEPLATE, AN AR-9502F-42LCPC ARTHREX UNIVERS REVERS SUTURE CUP, AN AR-9564-2842 ARTHREX UNIVERS REVERS MODULAR GLENOID SYSTEM GLENOSPHERE, AN AR-9503L-03 ARTHREX UNIVERS REVERS HUMERAL INSERT, (2) AR-9563-20 UNIVERS REVERS MODULAR GLENOID SYSTEM PERIPHERAL LOCKING SCREW, AN AR-9562-28NL UNIVERS REVERS MODULAR GLENOID SYSTEM PERIPHERAL NON-LOCKING SCREW, AN AR-9562-40NL UNIVERS REVERS MODULAR GLENOID SYSTEM PERIPHERAL NON-LOCKING SCREW, AN AR-9561-25P UNIVERS REVERS MODULAR GLENOID SYSTEM CENTRAL POST MODULA, AND AN AR-9501-05P UNIVERS REVERS HUMERAL STEM.

  Patient problems: Post Operative Wound Infection

  MAUDE report 16582155 ↗
• InjuryMar 15, 2021Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THROUGH THE SURGICAL OUTCOME SYSTEM THAT A REVISION SURGERY IS REQUIRED DUE TO THE LOOSENING OF AN ARTHREX PROSTHETIC JOINT. THE PRIMARY SURGERY TOOK PLACE ON (B)(6) 2020. THE COMPLICATION WAS REPORTED ON (B)(6) 2020; INDICATING LOOSENING OF PROSTHETIC JOINT AND A REVISION REQUIRED. THE REVISION SURGERY TOOK PLACE ON (B)(6) 2021. THE FOLLOWING ARTHREX PRODUCT WAS EXPLANTED DURING THE REVISION SURGERY; AR-9560-24 (LOT: 5655), AR-9561-20P (LOT: 7038), AR-9562-36NL (LOT: 2018005757), AR-9562-40NL (LOT: 2018001457), AR-9563-20 (LOT: 2019003063), AR-9564-2436-LAT (LOT: 19.03388), AR-9502F-36RCPC (LOT: 19.00394), AR-9503S-06 (LOT: 170052510). THE FOLLOWING ARTHREX PRODUCT WAS IMPLANTED DURING THE REVISION SURGERY; AR-9502F-36RCPC (LOT: 20.01053), AR-9555-06 (LOT: 170143213), AR-9503S-06 (LOT: 20.01369).

  Patient problems: Insufficient Information

  MAUDE report 11485338 ↗
• MalfunctionJan 12, 2021Improper or Incorrect Procedure or Method; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO RETRIEVE THE PROSTHESIS. IT WAS FURTHER REPORTED THAT THE DEFECTIVE PROSTHESIS WAS CAUSED DUE TO THE POST OPERATIVE ACTIONS BY THE PATIENT. THE PATIENT DID NOT FOLLOW THE POST OP GUIDELINES AND WAS OVERLOADING THE PROSTHESIS TOO EARLY IN THE GYM.

  Patient problems: Insufficient Information

  MAUDE report 11153789 ↗