Arthrex® AR-9582-35Recalls & reported problems
Arthrex, Inc. · MODULAR POST, 35MM · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867341869), received between Jun 7, 2021 and Jan 12, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
- Use of Device Problem1
Patient problems
- Bone Fracture(s)1
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 12, 2026Use of Device Problem
ON 22-DEC-2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-9582-35 MODULAR POST FOR AUGMENTED MGS BASEPLATE 35 MM EXPERIENCED AN ISSUE WITH INSERTING A SCREW INTO THE BASEPLATE. THIS OCCURRED DURING A REVERSE TOTAL SHOULDER REPLACEMENT ON (B)(6) 2025. THIS RESULTED IN HAVING TO REMOVE THE AR-9582-35 AND AN AR-9580-2420-2. THE CASE CONTINUED USING ANOTHER AR-9582-35 AND ANOTHER AR-9580-2420-2. THERE WAS NO DELAY IN THE PROCEDURE.
Patient problems: Insufficient Information
MAUDE report 24035272 ↗InjuryJun 7, 2021Detachment of Device or Device Component
IT WAS REPORTED THAT THE SURGEON WAS ATTEMPTING TO DO A 10 DEGREE AUGMENTED MGS GLENOID WITH A 35MM CENTRAL POST. AFTER IMPACTING THE GLENOSPHERE ONTO THE BASEPLATE, THE PATIENT'S GLENOID FRACTURED AND THE ENTIRE CONSTRUCT CAME LOOSE (SEE ATTACHED PICTURE). THE SURGEON WAS NOT SURE IF THEY WERE TOO ANTERIOR WITH THEIR INITIAL GUIDE PIN AND SUBSEQUENT REAMING, POSSIBLY WEAKENING THE BONE ANTERIORLY. THE SURGEON ALSO WENT BI-CORTICAL IN THE VAULT WITH THE CENTRAL POST ((B)(4)) AND DID NOT KNOW IF THIS ULTIMATELY LED TO THE FAILURE. THE SURGEON WAS ABLE TO USE BONE GRAFT FROM THE PATIENT'S RESECTED HUMERAL HEAD TO ADDRESS THE GLENOID FRACTURE AND THEN IMPLANTED A NON-AUGMENTED MGS BASEPLATE AND FINISHED THE PROCEDURE WITHOUT FURTHER ISSUE.
Patient problems: Bone Fracture(s)
MAUDE report 11946788 ↗
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- 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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