Arthrex® AR-9503-3336-3Recalls & reported problems
Arthrex, Inc. · Combination Humeral Insert 33+3 / 36 · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867406476), received between Mar 10, 2025 and Jan 23, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Positioning Failure” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Positioning Failure2
- Defective Device1
- Patient Device Interaction Problem1
Patient problems
- Insufficient Information2
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 23, 2026Positioning Failure
ON 08-JAN-2026, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-9503-3336-3 UNIVERS REVERS¿ MODULAR GLENOID SYSTEM WOULD NOT SEAT PROPERLY WHEN INSERTED INTO THE SHOULDER CUP. THIS OCCURRED DURING A REVERSE TOTAL SHOULDER ARTHROPLASTY PROCEDURE. THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER AR-9503-3336-3, WHICH ALLOWED THE PROCEDURE TO BE COMPLETED SUCCESSFULLY. THERE WERE NO PROCEDURAL DELAY AND NO PATIENT HARM ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24160165 ↗MalfunctionApr 22, 2025Positioning Failure; Defective Device; Positioning Failure; Defective Device
ON 2/25/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AR-9501-04-135P UNIVERS REVERS STEM WOULD NOT ENGAGE WITH AN AR-9504-06 UNIVERS REVERS SPACER. THE STEM WAS IMPLANTED OVER A MONTH AGO AND IT WOULD NOT ENGAGE. THIS WAS DISCOVERED DURING A REVISION SURGERY. NO FURTHER INFORMATION WAS REPORTED. ADDITIONAL INFORMATION RECEIVED ON 3/3/2025: THE PATIENT UNDERWENT AN INITIAL RTSA PROCEDURE ON (B)(6) 2024. ON (B)(6) 2025, THE PATIENT UNDERWENT A REVISION SURGERY IN WHICH TWO AR-9504-06 UNIVERS REVERS SPACERS WOULD NOT ENGAGE WITH THE STEM. ADDITIONAL INFORMATION RECEIVED ON 3/11/2025: THE PATIENT UNDERWENT REVISION SURGERY DUE TO A SHOULDER DISLOCATION. DURING THE REVISION, AN AR-9503XS-06 UNIVERS REVERS MODULAR GLENOID SYSTEM HUMERAL INSERT WAS EXPLANTED AND AN AR-9503-3336-6C UNIVERS REVERS MODULAR GLENOID SYSTEM, CONSTRAINED COMBO HUMERAL INSERT WAS IMPLANTED. ADDITIONAL INFORMATION RECEIVED ON 3/24/2025: AR-9564-2433-LAT ARTHREX UNIVERS REVERS GLENOSPHERE WERE EXPLANTED AS WELL. AR-9503-3336-3 UNIVERS REVERS COMBO HUMERAL INSERT WAS ATTEMPTED TO BE USED WITH THE SPACER BUT IT WOULD NOT FIT, SO THE SURGEON TURNED TO AN AR-9503-3336-6C UNIVERS REVERS MODULAR GLENOID
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21884134 ↗MalfunctionMar 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. 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 GLENOID SYSTEM GLENOSPHERE,
Patient problems: Insufficient Information
MAUDE report 21559785 ↗
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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