Arthrex® AR-9580-2420-2SRecalls & reported problems
Arthrex, Inc. · 24MM BASEPLATE, 20° FULL AUG, +2 LAT, ST · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00888867352117), received between May 22, 2024 and Apr 16, 2026 — classified as 4 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (3 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.
Reports received per month
Most reported problems
Device problems
- Patient Device Interaction Problem3
- Break2
- Detachment of Device or Device Component1
- Device Dislodged or Dislocated1
- Positioning Failure1
Patient problems
- Insufficient Information4
- Failure of Implant2
- Unspecified Infection2
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
InjuryApr 16, 2026Patient Device Interaction Problem
IT WAS REPORTED THAT AFTER AN INVERSE SHOULDER PROSTHESIS SURGERY ON (B)(6) 2026 THE PATIENT HAS DEVELOPED AN INFECTION. ON (B)(6) 2026 ALL IMPLANTS WERE REMOVED AND THE AFFECTED AREAS WERE CLEANSED AND TREATED. A NEW PROSTHESIS WILL BE IMPLANTED IN 6-8 WEEKS.
Patient problems: Unspecified Infection
MAUDE report 24895129 ↗MalfunctionDec 8, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT DURING THE INSERTION OF AN AR-9582-30 MODULAR POST AND AN AR-9580-2420-2S BASEPLATE, THE TWO COMPONENTS DID NOT ENGAGE PROPERLY, RESULTING IN SEPARATION. A SECOND SET OF COMPONENTS, ANOTHER POST AND BASEPLATE, WAS OPENED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THIS WAS DISCOVERED DURING A REVERSE TOTAL SHOULDER ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 11/25/2025: DURING THE PROCEDURE, THE AR-9582-30 MODULAR POST AND THE AR-9580-2420-2S BASEPLATE DISENGAGED INSIDE THE PATIENT AFTER BEING ASSEMBLED ON THE BACK TABLE. NO COMPONENTS BROKE, AND ALL PIECES WERE RETRIEVED. NO OTHER ARTHREX PRODUCTS WERE AFFECTED. THE CASE WAS COMPLETED USING AR-9580-2420-2S MODULAR GLENOID SYSTEM AUGMENTED BASE PLATE 24 MM+2 (LOT 1306512225) AND AR-9582-30 MODULAR POST FOR AUGMENTED MGS BASEPLATE 30 MM (LOT 1749132422). SURGERY WAS DELAYED BY APPROXIMATELY 5¿10 MINUTES; THE ADDITIONAL USE OF ANESTHESIA IS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 23745898 ↗InjuryAug 13, 2025Break; Break
ON 07/25/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT THE AR-9580-2420-2S UNIVERS REVERS MODULAR GLENOID SYSTEM AUGMENTED BASEPLATE (24 MM) HAD FAILED, NECESSITATING A REVISION PROCEDURE. THE ISSUE ORIGINATED DURING A REVERSE SHOULDER ARTHROPLASTY PERFORMED ON (B)(6) 2025. TO ADDRESS THE FAILURE, THE SURGICAL TEAM SUCCESSFULLY REMOVED THE AR-9580-2420-2S BASEPLATE (24 MM), AR-9582-30 MODULAR POST FOR AUGMENTED MGS BASEPLATE 30 MM, AR-9563-24 PERIPHERAL LOCKING SCREW, AND AR-9563-36 PERIPHERAL LOCKING SCREW. THEY PROCEEDED WITH THE IMPLANTATION OF A NON-ARTHREX SMALL SCREW BASEPLATE, WHICH WAS SUPPLEMENTED BY BONE GRAFTING. A NEW ARTHREX CUP AND POLYETHYLENE LINER WERE ALSO PLACED. THE REVISION SURGERY WAS COMPLETED WITHOUT FURTHER COMPLICATIONS. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON 07/31/2025.
Patient problems: Failure of Implant
MAUDE report 22792976 ↗InjuryMar 10, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
ON 2/11/2025, A CLINDEX NOTIFICATION WAS RECEIVED INDICATING THAT A PATIENT LISTED ON THE SHOULDER ARTHROPLASTY REGISTRY SUFFERED A BONE FRACTURE IN THE TARGETED SHOULDER. ABOUT SEVEN MONTHS POST OPERATION, THE PATIENT MADE A QUICK TURN AROUND AND ENDED UP FRACTURING THE GLENOID CAVITY OF RIGHT SCAPULA. THIS WAS CONFIRMED VIA A CT SCAN ON (B)(6) 2024. THE PATIENTS PAIN BEGAN TO IMPROVE AS OF (B)(6) 2024. THE PATIENT REPORTED DECREASED RANGE OF MOTION ON (B)(6) 2024 AND SHARP PAIN ON (B)(6) 2025 AND (B)(6) 2025. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2025. THIS EVENT WAS INDICATED AS UNRELATED TO THE UNIVERS REVERS SYSTEM IMPLANTED ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 2/21/2025: DURING THE REVISION SURGERY ON (B)(6) 2024, AN AR-9550-19RCA UNIVERS REVERS CA HUMERAL HEAD, AN AR-9501-04-135R UNIVERS REVERS STEM, AN AR-9503-3336-3 UNIVERS REVERS MODULAR GLENOID SYSTEM HUMERAL INSERT, AN AR-9563-16 UNIVERS REVERS MODULAR GLENOID SYSTEM PERIPHERAL SCREW, AN AR-9563-24 UNIVERS REVERS MODULAR GLENOID SYSTEM, PERIPHERAL SCREW, LOCKING, AN AR-9563-28 UNIVERS REVERS MODULAR GLENOID SYSTEM, PERIPHERAL SCREW, LOCKING, AN AR-9564-2436 ARTHREX UNIVERS REVERS MODULAR GLENO
Patient problems: Insufficient Information
MAUDE report 21559754 ↗MalfunctionFeb 11, 2025Break; Break
ON (B)(6) 2024, A CLINDEX NOTIFICATION WAS RECEIVED INDICATING THAT A PATIENT LISTED ON THE SHOULDER ARTHROPLASTY REGISTRY EXPERIENCED LOOSENING OF THE GLENOID SIDE IMPLANTS ON (B)(6) 2024. ON (B)(6) 2024, THE PATIENT UNDERWENT REVISION SURGERY TO HAVE THE BASEPLATE REMOVED AND HAD A CTA HEAD IMPLANTED. THIS EVENT WAS INDICATED TO BE RELATED TO THE UNIVER REVERS IMPLANT SYSTEM IMPLANTED ON (B)(6) 2023. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED ON 1/15/2025: THE PATIENT'S INITIAL PROCEDURE WAS ON (B)(6) 2023, AND AN ARTHREX UNIVERS REVERS SYSTEM WAS IMPLANTED. THE PATIENT SUFFERED A FALL AROUND (B)(6) 2023, RESULTING IN A MEDIAL BODY SCAPULAR FRACTURE. AN ORIF PROCEDURE WAS PERFORMED ON (B)(6) 2024. NO INFORMATION WAS PROVIDED REGARDING THE SURGERY ON (B)(6) 2024. A POST-OPERATIVE X-RAY AND CT ON (B)(6) 2024 CONFIRMED THAT THE MEDICAL ASPECT OF THE DURAL PLATING WAS INTACT, BUT THE PATIENT HAD A FRACTURE DISTALLY OVER THE ACROMION, WHICH HAD NOT HEALED. X-RAYS ON (B)(6) 2024 ALSO CONFIRMED PROGRESSIVE LOOSENING OF THE PATIENT'S REVERSE PROSTHESIS, WITH A MARKEDLY ANTEVERTED GLENOID BASEPLATE. THE ACROMION BROKE OFF AND WAS SITTING IN THE SOFT TISSUES O
Patient problems: Failure of Implant
MAUDE report 21357563 ↗InjuryJan 15, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
ON 12/18/2024, A CLINDEX NOTIFICATION WAS RECEIVED INDICATING THAT A PATIENT LISTED ON THE SHOULDER ARTHROPLASTY REGISTRY, FIVE MONTHS POSTOPERATIVE, PRESENTED WITH FULLNESS IN THE ANTERIOR OF THE DELTOPECTORAL INCISION, WHICH HAS TO BE FLUCTUANCE. THE INCISION WAS DRAINED, AND A CULTURE WAS SENT TO THE LAB, WHICH INDICATED AN INFECTION. THE PHYSICIAN DECIDED TO PLACE A PICC LINE FOR IV ANTIBIOTICS. THE PATIENT ALSO UNDERWENT AN EXPLANT PROCEDURE AND HAD AN ANTIBIOTIC CEMENT SPACER IMPLANTED ON (B)(6) 2024. THE PATIENT WAS ORIGINALLY IMPLANTED ON (B)(6) 2024. THIS EVENT WAS INDICATED AS UNRELATED TO THE UNIVERS REVERS APEX IMPLANT SYSTEM. ADDITIONAL INFORMATION RECEIVED ON 1/3/2024: DURING THE REVISION SURGERY, AN AR-9503-3639-3 HUMERAL INSERT, AN AR-9563-16 PERIPHERAL SCREW, AN AR-9563-24 PERIPHERAL SCREW, AN AR-9563-32 PERIPHERAL SCREW, AN AR-9563-44 PERIPHERAL SCREW, AN AR-9564-2439-LAT GLENOSPHERE, AN AR-9580-2420-2S BASEPLATE, AND AR-9582-25 MODULAR POST WERE EXPLANTED. THE REVISION SURGERY WAS COMPLETED USING PRODUCTS FROM ANOTHER MANUFACTURER.
Patient problems: Unspecified Infection
MAUDE report 21160447 ↗MalfunctionJun 7, 2024Positioning Failure; Positioning Failure
ON (B)(6) 2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AR-9582-30 MODULAR POST AND AN AR-9580-2420-2S AUGMENTED BASEPLATE DID NOT LOCK. SURGEON ATTEMPTED TO IMPLANT THEM MULTIPLE TIMES BUT IT WOULD NOT SEAT. THIS WAS DISCOVERED DURING A REVERSE TOTAL SHOULDER REPLACEMENT PROCEDURE ON (B)(6) 2022. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2022: SURGEON REMOVED BOTH THE BASEPLATE AND POST FROM THE PATIENT AND USED AN AR-9580-2410-2 BASEPLATE AND AR-9582-30 MODULAR POST TO COMPLETE THE CASE WITHOUT FURTHER ISSUES. NOTHING BROKE OFF INSIDE THE PATIENT.
Patient problems: Insufficient Information
MAUDE report 19483172 ↗MalfunctionMay 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9580-2420-2S UNIVERS REVERS MODULAR GLENOID SYSTEM AUGMENTED BASEPLATE IS LOOSE. NO FURTHER INFORMATION HAS BEEN PROVIDED. ADDITIONAL INFORMATION REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19370965 ↗
Other shoulder prosthesis, reverse configuration devices
- DJO SURGICAL 508-36-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration508 reports
- DJO SURGICAL 508-32-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration433 reports
- DJO SURGICAL 508-32-103Encore Medical, L.P. · shoulder prosthesis, reverse configuration421 reports
- DJO SURGICAL 509-00-036Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall259 reports
- DJO SURGICAL 508-32-104Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall203 reports
- DJO SURGICAL 509-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration233 reports
- DELTA XTEND 130760000Depuy (Ireland) · shoulder prosthesis, reverse configuration223 reports
- DJO SURGICAL 508-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration122 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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