Arthrex® AR-9560-28-2Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867296503), received between Oct 10, 2022 and Apr 4, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 4, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 10/11/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT WHILE THE SURGEON WAS USING AN AR-9622 TAPER ASSEMBLY PRESS WAS USED TO PAIR THE AR-9560-28-2, 28MM +2 LAT. MGS BASEPLATE AND AR-9561-35S, 35MM CENTRAL SCREW, BUT UPON INSERTION THE BASEPLATE AND CENTRAL SCREW DISASSOCIATED. THIS WAS DISCOVERED DURING A REVERSE TOTAL SHOULDER ARTHROPLASTY ON 10/5/2021. THE CASE WAS COMPLETED BY REMOVING THE CENTRAL SCREW FROM THE GLENOID WITH REMOVAL DRIVER AND THEN OPENED NEW IMPLANTS WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19042471 ↗
• MalfunctionMar 20, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A UNIVERS REVERS SURGERY WITH A MODULAR GLENOID SYSTEM THE BASEPLATE AND CENTRAL SCREW WERE DISLOCATED DURING IMPLANTATION. THE BASEPLATE AND CENTRAL SCREW WERE ASSEMBLED CORRECTLY. THE BASEPLATE WAS SEATED CORRECTLY ON THE PRESS, THE CENTRAL SCREW WAS PLACED CORRECTLY (PLACED, ROTATED UNTIL THE HEX PIN ENGAGES AND THERE IS NO LONGER A VISIBLE GAP BETWEEN THE BASEPLATE AND CENTRAL SCREW) AND TIGHTENED CORRECTLY UNTIL THE DISPLAY SHOWS BETWEEN THE MIN AND MAX MARKINGS. WHEN IMPLANTING THE BASEPLATE AND CENTRAL SCREW, THE BASEPLATE COULD NOT BE SCREWED IN SUFFICIENTLY DUE TO HARD BONE SO THAT THE BACK OF THE BASEPLATE LAID ON THE GLENOID WITH SATISFACTORY COMPRESSION. THE SURGEON THEN TRIED TO TIGHTEN THE BASEPLATE FURTHER USING THE BASEPLATE EXTRACTOR AND BASEPLATE EXTRACTOR WRENCH, BUT THE BASEPLATE BECAME DETACHED FROM THE CENTRAL SCREW. THE CENTRAL SCREW REMAINED IN THE GLENOID AND COULD BE REMOVED BY USING A 4MM HEX DRIVER. THE THREAD WAS THEN RECUT WITH THE THREAD CUTTER AND A NEW BASEPLATE WITH A NEW CENTRAL SCREW WAS INSERTED. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY. IT WAS NOT NECESSARY TO SWIT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18944662 ↗
• MalfunctionOct 10, 2022Material Separation; Defective Device; Positioning Problem; Defective Device

  IT WAS REPORTED ON 09/22/2022 BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9560-28-2 BASEPLATE AND AR-9561-25S MODULAR SCREW WOULD NOT COMPRESS TOGETHER WITH THE MORSE TAPER USING THE TAPER ASSEMBLY PRESS. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM. PER FACILITY: " IT WAS CONFIRMED THAT THE COMPRESSION LINE BETWEEN MAXIMUM AND MINIMUM WAS ACHIEVED BUT UP INSERTING THE IMPLANT THE TWO PIECES BECAME DISASSEMBLED. WE WERE ABLE TO RETRIEVE BOTH PARTS SAFELY WITHOUT HARMING THE PATIENT. WE THEN ASSEMBLED TWO NEW PARTS, SAME SIZES, AND IN THE SAME FASHION WITHOUT ISSUES."

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15571772 ↗