Arthrex® AR-9503-3336-6Recalls & reported problems
Arthrex, Inc. · Combination Humeral Insert 33+6 / 36 · Class 2 · Implant
Data updated Oct 18, 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 00888867406827), received between Oct 31, 2023 and Aug 8, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Fitting 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Fitting 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.
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 19941179 ↗MalfunctionOct 31, 2023Fitting Problem; Fitting Problem
ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-9503-3633-6 UNIVERS REVERS MODULAR GLENOID SYSTEM COMBO HUMERAL INSERT AND AN AR-9503-3336-6 COMBINATION HUMERAL INSERT WOULD NOT SIT PROPERLY. THE SURGEON HAD TO USE AN AR-9562-36NL UNIVERS REVERS NON-LOCKING PERIPHERAL SCREW, TO REMOVE THE HUMERAL INSERT. THE CASE WAS DELAYED FOR ABOUT TEN MINUTES, AND IT WAS COMPLETED USING AN AR-9504-06 HUMERAL SPACER AND AN AR-9503-3336-3 COMBINATION HUMERAL INSERT. THIS WAS DISCOVERED DURING AN RTS PROCEDURE ON (B)(6) 2023.
Patient problems: Insufficient Information
MAUDE report 18040308 ↗
Other shoulder prosthesis, reverse configuration devices
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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