Arthrex® AR-9580-2420Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888867341647), received between Apr 18, 2023 and Mar 4, 2026 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMar 4, 2026Positioning Failure

  ON 28-JAN-2026, THE PATIENT REPORTED VIA EMAIL THAT, FOLLOWING A REVERSE TOTAL SHOULDER SURGERY, THEY EXPERIENCED INCREASING POSTOPERATIVE PAIN. X-RAYS REPORTEDLY SHOWED A BROKEN SCREW, AND A CT SCAN DEMONSTRATED A LOOSE IMPLANT. THE PATIENT IS NOW SCHEDULED FOR A CORRECTIVE SURGICAL PROCEDURE. NO ADDITIONAL DETAILS WERE PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED VIA PHONE FROM THE PATIENT'S RELATIVE ON 09-FEB-2026: THE PATIENT IS SCHEDULED TO UNDERGO A REVISION LEFT REVERSE TOTAL SHOULDER ARTHROPLASTY ON (B)(6) 2026. THE ORIGINAL PROCEDURE WAS PERFORMED ON (B)(6) 2024 BY A DIFFERENT SURGEON AT A DIFFERENT FACILITY. OVER TIME, THE PATIENT DEVELOPED SIGNIFICANT LEFT SHOULDER PAIN. THE PATIENT¿S SPOUSE REPORTED PROGRESSIVE DISCOMFORT IN THE PATIENT¿S LEFT ARM. DIAGNOSTIC IMAGING WAS PERFORMED, INCLUDING AN X-RAY ON (B)(6) 2025, WHICH IDENTIFIED A FRACTURED SCREW, FOLLOWED BY A CT SCAN ON (B)(6) 2025 THAT DEMONSTRATED LOOSENING OF THE IMPLANT. ADDITIONAL INFORMATION WAS RECEIVED VIA PHONE FROM THE PATIENT'S RELATIVE ON 10-FEB-2026: THE PATIENT'S SPOUSE REPORTED THAT THE REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, ALL COMPONENTS OF THE LEFT SHOULDER WERE R

  Patient problems: Discomfort; Pain

  MAUDE report 24507100 ↗
• MalfunctionAug 11, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  ON 07/24/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-9580-2420 24MM BASEPLATE, 20° FULL AUGMENT, AND AN AR-9582-30 MODULAR POST BECAME LOOSE AFTER 1.5 YEARS POST-IMPLANTATION. THERE WERE NO SIGNS OF INFECTION, AND THE SURGEON CONFIRMED NO HISTORY OF TRAUMA OR FALL. THE ISSUE WAS IDENTIFIED ON (B)(6) 2025. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON (B)(6) 2025.

  Patient problems: Failure of Implant

  MAUDE report 22773242 ↗
• MalfunctionApr 25, 2024Fitting Problem; Fitting Problem

  ON (B)(6) 2021 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-9582-30 MODULAR POST AND AR-9582-2420 24 MM BASEPLATE WOULD NOT FUSE OR TENSION TOGETHER. THIS WAS DISCOVERED ON THE BACK TABLE DURING USE IN A RTSA ON (B)(6) 2021. THE CASE WAS COMPLETED BY OPEN A NEW AR-9582-30 AND AR-9582 2420.

  Patient problems: Insufficient Information

  MAUDE report 19183290 ↗
• MalfunctionApr 9, 2024Defective Device; Defective Device

  ON 9/16/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-9580-2420 24MM BASEPLATE AND AN AR-9582-25 MODULAR POST HAD AN ISSUE DURING A REVERSE TOTAL SHOULDER ARTHROPLASTY ON(B)(6^) 2022. THE BASEPLATE WAS PREPARED WITH THE MODULAR POST ON THE BACK TABLE, WITH THE DESIRED LENGTH, AND THEN PUT INTO THE PATIENT. IT WAS NOTICED THAT DURING THE SCREW INSERTION, THE BASEPLATE ROTATED SLIGHTLY AND WAS LOOSE INSIDE THE PATIENT. THE SCREWS WERE TAKEN OUT AND THE BASEPLATE WITH THE MODULAR POST WAS TAKEN OUT OF THE PATIENT. A DIFFERENT IMPLANT WAS USED, PART AND LOT NUMBER UNKNOWN, AND A LONGER POST, PART, AND LOT NUMBER UNKNOWN, WERE USED TO COMPLETE THE PROCEDURE SUCCESSFULLY NO IMPACT TO THE PATIENT. NOTHING BROKE INSIDE THE PATIENT. THE COMPLAINT DEVICES WERE AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19071127 ↗
• InjuryJul 20, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 6/26/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT A PATIENT UNDERWENT A REVISION SHOULDER ARTHROPLASTY PROCEDURE ON (B)(6) 2023 DUE TO AN INFECTION AND LOOSENED BASEPLATE. IN (B)(6) 2023, THE PATIENT COMPLAINED OF PAIN AFTER THE ORIGINAL PROCEDURE ON (B)(6) 2023. DURING THE POST-OPERATIVE VISIT, RADIOGRAPHS INDICATED A LOOSENED BASEPLATE, BUT THE INFECTION TYPE WAS NOT YET CONFIRMED. DURING THE REVISION SURGERY, AN AR-9564-2433-LAT GLENOSPHERE, AN AR-9580-2420 BASEPLATE, AN AR-9582-20 MODULAR POST, AN AR-9501-10S HUMERAL STEM, AN AR-9502F-33CPC SUTURE CUP, AN AR-9503XS-03 HUMERAL INSERT, AN AR-9504-06 HUMERAL SPACER, AN AR-9562-24NL PERIPHERAL NON-LOCKING SCREW, AN AR-9563-16 PERIPHERAL LOCKING SCREW, AN AR-9563-20 PERIPHERAL LOCKING SCREW, AND AR-9563-24 PERIPHERAL LOCKING SCREW WERE EXPLANTED. THE CASE WAS COMPLETED BY TAKING CULTURES FOR FURTHER TESTING AND PLACING ANTIBIOTIC SPACERS. NO ADDITIONAL ARTHREX PRODUCTS WERE IMPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 17363847 ↗
• InjuryApr 18, 2023Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT A REVISION SHOULDER ARTHROPLASTY PROCEDURE TOOK PLACE ON(B)(6) 2023 DUE TO AN INFECTION. THE SURGEON REMOVED AN AR-9580-2420 UNIVERS REVERS MODULAR GLENOID SYSTEM AUGMENTED BASEPLATE, AN AR-9582-20 MODULAR POST FOR AUGMENTED MGS BASEPLATE, AN AR-9562-32NL UNIVERS REVERS MODULAR GLENOID SYSTEM, PERIPHERAL SCREW, NON-LOCKING 4.5 X 32 MM, AN AR-9562-24NL UNIVERS REVERS MODULAR GLENOID SYSTEM, PERIPHERAL SCREW, NON-LOCKING 4.5 X 24 MM, AN AR-9563-20 UNIVERS REVERS MODULAR GLENOID SYSTEM, PERIPHERAL SCREW, LOCKING 5.5 X 20 MM, AN AR-9563-16 UNIVERS REVERS MODULAR GLENOID SYSTEM, PERIPHERAL SCREW, LOCKING 5.5 X 16 MM, AN AR-9564-2436-LAT ARTHREX UNIVERS REVERS MODULAR GLENOID SYSTEM GLENOSPHERE, AN AR-9503S-06 ARTHREX UNIVERS REVERS HUMERAL INSERT, AN AR-9502F-36CPC ARTHREX UNIVERS REVERS SUTURE CUP, AND AN AR-9501-05P UNIVERS REVERS HUMERAL STEM. ADDITIONAL INFORMATION RECEIVED ON 3/23/2023: THE ORIGINAL PROCEDURE OCCURRED ON 3/22/2021. ABOUT TEN MONTHS LATER, THE PATIENT STARTED TO EXPERIENCE SYMPTOMS OF INFECTION. A CULTURE WAS TAKEN OFF THE INFECTED AREAS, BUT RESULTS ARE STILL PENDING. THE SAME SURGEON AT THE S

  Patient problems: Unspecified Infection

  MAUDE report 16762004 ↗