Arthrex® AR-9502F-42LCPCRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867234260), received between Dec 20, 2019 and May 21, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Defective Device” (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.

• MalfunctionMay 21, 2024Defective Device; Defective Device

  ON 04/23/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9502F-42LCPC ARTHREX UNIVERS REVERS SUTURE CUP WOULD NOT SCREW INTO THE STEM. A NEW SUTURECUP WAS USED TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 4/26/2024: AR-9502F-42LCPC ARTHREX UNIVERS REVERS SUTURE CUP WOULD NOT SCREW INTO AN AR-9501-12S UNIVERS REVERS APEX HUMERAL STEM. A NEW AR-9502F-42LCPC ARTHREX UNIVERS REVERS SUTURE CUP WAS USED TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING A REVERS TOTAL SHOULDER PROCEDURE. THE CASE WAS NOT DELAYED. ADDITIONAL ANESTHESIA WAS UNNECESSARY, AND THE PATIENT SUFFERED NO NEGATIVE EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19359113 ↗
• 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 16582040 ↗
• 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: Atrial Fibrillation; Failure of Implant; Hematoma; Tissue Breakdown

  MAUDE report 9506061 ↗