Arthrex® AR-9580-2410-2Recalls & reported problems
Arthrex, Inc. · 24MM BASEPLATE, 10° FULL AUG, +2 LAT, OB · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867341685), received between Aug 8, 2024 and Nov 18, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Patient Device Interaction Problem1
Patient problems
- Bone Fracture(s)1
- Insufficient Information1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 18, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
ON 10/28/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT TWO AR-9502-39ARCA UNIVERS REVERS CA HUMERAL HEAD ADAPTER 39 COMPONENTS COULD NOT BE SECURED DURING SURGERY. THE PROCEDURE WAS A REVISION REVERSE SHOULDER ARTHROPLASTY ON (B)(6) 2025. DURING THE OPERATION, THE ORIGINAL LINER WAS REMOVED FROM THE PATIENT. WHEN ATTEMPTING TO PLACE BOTH AR-9502-39ARCA UNIVERS REVERS CA HUMERAL HEAD ADAPTER 39 INTO THE 39 SUTURE CUP, NEITHER ADAPTER WOULD SNAP INTO PLACE. ADDITIONAL INFORMATION WAS RECEIVED ON 11/03/2025: THE PATIENT UNDERWENT A REVISION REVERSE SHOULDER ARTHROPLASTY ON (B)(6) 2025 FOLLOWING A FALL-RELATED INCIDENT. DURING THE PROCEDURE, ATTEMPTS TO IMPLANT TWO COMPONENTS, AR-9502-39ARCA UNIVERS REVERS CA HUMERAL HEAD ADAPTER 39 AND AR-9556-22RCA UNIVERS REVERS CA HUMERAL HEAD 56/22, WERE UNSUCCESSFUL AS THEY COULD NOT BE SECURED. THIS ISSUE EXTENDED THE SURGICAL TIME BY APPROXIMATELY 30 MINUTES. AS PART OF THE REVISION, ALL IMPLANTS FROM THE ORIGINAL REVERSE SHOULDER ARTHROPLASTY PERFORMED IN (B)(6) 2023 WERE EXPLANTED. THE ORIGINAL SURGERY WAS PERFORMED AT THE SAME FACILITY BY THE SAME SURGEON AND HAD NO REPORTED INTRAOPERATIVE COMPLICATIONS. THE ARTHREX PRODUCTS IMPLANTED
Patient problems: Insufficient Information
MAUDE report 23586411 ↗InjuryAug 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON 7/18/2024, A CLINDEX NOTIFICATION WAS RECEIVED INDICATING THAT A PATIENT LISTED ON THE SHOULDER ARTHROPLASTY REGISTRY SUFFERED BONE FRACTURES IN THE TARGET SHOULDER. THIS EVENT WAS INDICATED AS POSSIBLY RELATED TO THE UNIVERS REVERS DEVICES IMPLANTED ON (B)(6) 2024. ON (B)(6) 2024, THE PATIENT STARTED TO EXPERIENCE PAIN. IT WAS SUSPECTED THE PATIENT SUFFERED AN ACROMIAL FRACTURE, WHICH WAS CONFIRMED IN APRIL VIA CT SCAN. THE PATIENT WAS IMMOBILIZED IN A SLING FOR SIX WEEKS. ON (B)(6) 2024, THE PATIENT REPORTED NO PAIN; X-RAY IMAGES REVEALED A HEALED FRACTURE. THE PATIENT DID NOT SUFFER A FALL OR HAVE AN INJURY. THE PAIN BEGAN AFTER PHYSICAL THERAPY. THE IMPLANTS ARE NOT LOOSE OR BROKEN.
Patient problems: Bone Fracture(s); Pain
MAUDE report 19940155 ↗
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- 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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