Arthrex® AR-9555-09Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867062481), received between Sep 2, 2020 and May 16, 2024 — classified as 2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 16, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 4/19/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9555-09 UNIVERS REVERS SPACER WAS LOOSE AFTER IMPLANTATION. THE AR-9501-06S UNIVERS REVERS APEX STEM AND AR-9502F-36CPC UNIVERS REVERS SUTURECUP ATTACHED PERFECTLY FINE IN THE ASSEMBLY BLOCK. THE AR-9555-09 UNIVERS REVERS SPACER WAS PLACED IN THE PATIENT, AND THE APPROPRIATE DRIVER WAS USED TO TIGHTEN THE ASSEMBLY SCREW. APPROPRIATE TORQUE WAS APPLIED, AND AN AR-9503S-03 UNIVERS REVERS HUMERAL INSERT WAS IMPACTED. ONCE THE UNIVERS REVERS HUMERAL INSERT WAS IMPACTED, IT WAS OBSERVED THAT THE UNIVERS REVERS SPACER HAD, IN FACT, SOMEHOW REMAINED LOOSE. THE ENTIRE CONSTRUCT NEEDED TO BE REMOVED BECAUSE THE UNIVERS REVERS SPACER COULD NOT BE DISASSOCIATED FROM THE UNIVERS REVERS SUTURECUP. THE SURGERY OUTCOME WAS NOT IMPACTED, AND THE SURGEON WAS ABLE TO COMPLETE THE SURGERY WITH REPLACEMENTS WE HAD AVAILABLE. THE PATIENT WAS NOT AFFECTED. THIS WAS DISCOVERED DURING AN APEX STEM CONSTRUCT PROCEDURE. ADDITIONAL INFORMATION RECEIVED ON 4/25/2024: THE CASE WAS DELAYED ONLY BETWEEN TEN TO FIFTEEN MINUTES. ADDITIONAL ANESTHESIA WAS UNNECESSARY, AND THE PATIENT SUFFERED NO NEGATIVE EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19329981 ↗
• InjuryFeb 13, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 1/17/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9660-R CENTRAL POST EXTRACTOR GOT STUCK IN THE IMPLANT DURING IMPLANT REMOVAL. THIS WAS DISCOVERED DURING A REVISION REVERSE TOTAL SHOULDER PROCEDURE ON (B)(6) 2024. NO FURTHER INFORMATION WAS REPORTED. ADDITIONAL INFORMATION RECEIVED ON 1/31/2024: THE ORIGINAL PROCEDURE OCCURRED ON (B)(6) 2021. DUE TO PAIN, THE PATIENT UNDERWENT REVISION SURGERY. DURING THE REVISION SURGERY ON (B)(6) 2024, AN AR-9503S-03 HUMERAL INSERT, AN AR-9555-09 UNIVERS REVERS SPACER, AN AR-9563-16 PERIPHERAL LOCKING SCREW, AN AR-9563-20 PERIPHERAL LOCKING SCREW, AN AR-9563-24 PERIPHERAL LOCKING SCREW, AN AR-9563-28 PERIPHERAL LOCKING SCREW, AN AR-9564-2436 GLENOSPHERE, AN AR-9580-2410-2 BASEPLATE, AND AN AR-9582-25 MODULAR POST WERE EXPLANTED. ONLY AN AR-9501-10S UNIVERS REVERS APEX STEM AND AN AR-9502F36RCPC SUTURE CUP REMAINED FROM THE ORIGINAL SURGERY. TO COMPLETE THE REVISION SURGERY, AN AR-9503S-03C HUMERAL INSERT, AN AR-9555-12 UNIVERS REVERS SPACER, AN AR-9560-24-4 BASEPLATE, AN AR-9561-30S CENTRAL SCREW, AN AR-9563-16 PERIPHERAL LOCKING SCREW, AN AR-9563-20 PERIPHERAL LOCKING SCREW, (2) AR-9563-28 PERIPHERAL LOCKING SCREW,

  Patient problems: Implant Pain

  MAUDE report 18695124 ↗
• InjurySep 2, 2020Break; Corroded; Unstable; Positioning Problem

  IT WAS REPORTED THAT THE PATIENT HAD UNDERGONE AN INITIAL REVISION SURGERY ON (B)(6) 2018 DURING WHICH THE FOLLOWING DEVICES WERE IMPLANTED: AR-9120-01 (LOT 170115215), AR-9145-36 (LOT 170037012), AR-9145-30 (LOT 170057712), AR-9504S-04 (LOT 170091414), AR-9555-09 (LOT 2501367202), AR-9503S-03C (LOT 2501374603), AR-9165-25 (LOT 2501357504). THE (B)(6) 2018 PROCEDURE WAS A REVISION OF ARTHREX PRODUCTS BECAUSE THE PATIENT HAD GLENOID INSTABILITY DUE TO BASEPLATE PLACEMENT ON THE PRIMARY. IT IS UNKNOWN IF THE 2018 REVISION WAS EVER REPORTED TO ARTHREX AS NO DETAILS FROM THE ORIGINAL SURGERY ARE KNOWN TO SEARCH/MATCH PART NUMBERS. THE IMPLANTS PUT IN ON (B)(6) 2018 WERE DONE SO IN A COMPROMISED GLENOID WITH POOR BONE QUALITY. THE PERIPHERAL SCREWS BROKE AND LED TO BASEPLATE FAILURE. THE GLENOSPHERE REMAINED ENGAGED IN THE BASEPLATE. THERE WAS SIGNIFICANT CORROSION OF THE HUMERAL POLY INSERT. THE GLENOID COMPONENTS FAILED NEARLY TWO YEARS AGO BUT THE PATIENT WAITED UNTIL (B)(6) 2020 TO HAVE A REVISION SURGERY. THE SALES REPRESENTATIVE REPORTED THAT THE SURGEON ATTRIBUTED THE FAILURE TO PUTTING THE BASEPLATE ON HER ORIGINAL REVERSE PROCEDURE TOO SUPERIOR ON THE FACE OF THE GLENOID WITH S

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10482829 ↗