Arthrex® AR-9564-2442-LATRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867295742), received between Dec 20, 2019 and Nov 8, 2024 — classified as 3 injuries.

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

• InjuryNov 8, 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 10/16/23 THE PATIENT UNDERWENT A REVISION SURGERY IN WHICH A NEW GLENOSPHERE ALONG WITH HUMERAL COMPONENTS WERE IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 20640183 ↗
• InjuryApr 21, 2023Fitting Problem; Fitting Problem

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9564-2442-LAT ARTHREXUNIVERS REVERS MODULAR GLENOID SYSTEM GLENOSPHERE WOULD SPIN AROUND THE BASEPLATE WHEN THE SCREW WAS ATTEMPTING TO BE TORQUED. THIS WAS DISCOVERED DURING A REVISION REVERSE TOTAL SHOULDER PROCEDURE ON (B)(6) 2023. A NEW GLENOSPHERE WAS USED TO COMPLETE THE CASE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information

  MAUDE report 16785318 ↗
• InjuryDec 20, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA THE SURGICAL OUTCOME SYSTEM THAT A PATIENT WAS HAVING COMPLICATIONS POSSIBLY RELATED TO A PRIOR IMPLANTED ARTHREX PRODUCT. COMPLICATIONS MENTIONED WERE HEMATOMA. ADDITIONAL INFORMATION OBTAINED 12/3/2019: THE SURGEON'S REPRESENTATIVE HAS CONFIRMED THAT A PATIENT HAD AN INITIAL PRIOR ROTATOR CUFF REPAIR AND REQUIRED A SECOND LEFT REVERSE SHOULDER ARTHROPLASTY ON (B)(6) 2019. THE OPERATIVE REPORT FROM (B)(6) 2019 NOTED THAT THREE METAL CORKSCREW ANCHORS HAD BEEN EXPLANTED PRIOR TO PROCEEDING WITH THE PROCEDURE. DURING THE PROCEDURE THE FOLLOWING ARTHREX PRODUCTS WERE IMPLANTED: AR-9564-2442-LAT (MODULAR GLENOSPHERE), AR-9501-07S (HUMERAL STEM) AND AR-9502F-42LCPC (SUTURE CUP). ON (B)(6) 2019 THE PATIENT WAS ADMITTED TO THE HOSPITAL URGENTLY AFTER HIS LARGE HEMATOMA BEGAN TO HAVE WOUND BREAKDOWN AND HE HAD ANEMIA WITH SYMPTOMATIC ATRIAL FIBRILLATION WITH RVR. SURGEON ADMITTED THE PATIENT FOR SURGICAL EXPLORATION WITH EVACUATION OF HEMATOMA, DEBRIDEMENT, EXPLORATION OF TENDON TRANSFER SITE AND ADMINISTRATION OF LOCAL ANTIBIOTICS. OPERATIVE REPORT NOTED THERE WAS NO EVIDENCE OF INFECTION AND THE SUBSCAPULARIS REPAIR AND THE TENDON TRANSFER REPAIR WERE INTACT. THE PRO

  Patient problems: Anemia; Atrial Fibrillation; Hematoma; Tissue Breakdown

  MAUDE report 9506054 ↗