Arthrex® AR-9564-2842Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867295803), received between Jan 12, 2021 and Jul 24, 2023 — classified as 1 injury, 3 malfunctions.

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

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 24, 2023Environmental Particulates; Environmental Particulates

  IT WAS REPORTED THAT DURING AN INVERSE PROTHESIS SURGERY THE GLENOSPHERE SHOWS DUST PARTICLES AFTER OPENING THE PACKAGING. ONE GLENOSPHERE WAS DISCARDED, THE SECOND WAS IMPLANTED. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. (B)(6)2023: THE DEVICE WAS OPENED WHEN PATIENT WAS ALREADY UNDER ANAESTHESIA. NO THIRD DEVICE WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17380040 ↗
• MalfunctionJul 24, 2023Environmental Particulates; Environmental Particulates

  IT WAS REPORTED THAT DURING AN INVERSE PROTHESIS SURGERY THE GLENOSPHERE SHOWS DUST PARTICLES AFTER OPENING THE PACKAGING. ONE GLENOSPHERE WAS DISCARDED, THE SECOND WAS IMPLANTED. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE SWIT (B)(6)2023: THE DEVICE WAS OPENED WHEN PATIENT WAS ALREADY UNDER ANAESTHESIA. NO THIRD DEVICE WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17380010 ↗
• 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 16582169 ↗
• MalfunctionJan 12, 2021Adverse Event Without Identified Device or Use Problem; 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 11153720 ↗