Arthrex® AR-9504-06Recalls & reported problems
Arthrex, Inc. · Humeral Spacer 33+6mm · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867406902), received between Jul 20, 2023 and Mar 19, 2025 — classified as 1 injury, 2 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Positioning Failure2
- Patient Device Interaction Problem1
Patient problems
- Insufficient Information2
- Unspecified Infection1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 19, 2025Positioning Failure; Positioning Failure
ADDITIONAL INFORMATION RECEIVED ON 3/24/025: 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 SYSTEM, CONSTRAINED COMBO HUMERAL INSERT . IT WAS ALSO REPORTED THAT THE SCREW FROM THE INITIAL AR-9504-06 UNIVERS REVERS SPACER WAS NOT WORKING AND AN AR-9502RSC UNIVERS REVERS REPLACEMENT CUP SCREW HAD TO BE USED.
Patient problems: Insufficient Information
MAUDE report 21641445 ↗MalfunctionMar 18, 2025Positioning Failure; Positioning Failure
ADDITIONAL INFORMATION RECEIVED ON 3/24/025: 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 SYSTEM, CONSTRAINED COMBO HUMERAL INSERT. IT WAS ALSO REPORTED THAT THE SCREW FROM THE INITIAL AR-9504-06 UNIVERS REVERS SPACER WAS NOT WORKING AND AN AR-9502RSC UNIVERS REVERS REPLACEMENT CUP SCREW HAD TO BE USED.
Patient problems: Insufficient Information
MAUDE report 21633534 ↗InjuryJul 20, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
ON 6/26/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT A PATIENT UNDERWENT A REVISION SHOULDER ARTHROPLASTY PROCEDURE ON (B)(6) 2023 DUE TO AN INFECTION AND LOOSENED BASEPLATE. ON (B)(6) 2023, THE PATIENT COMPLAINED OF PAIN AFTER THE ORIGINAL PROCEDURE ON (B)(6) 20203. DURING THE POST-OPERATIVE VISIT, RADIOGRAPHS INDICATED A LOOSENED BASEPLATE, BUT THE INFECTION TYPE WAS NOT YET CONFIRMED. DURING THE REVISION SURGERY, AN AR-9564-2433-LAT GLENOSPHERE, AN AR-9580-2420 BASEPLATE, AN AR-9582-20 MODULAR POST, AN AR-9501-10S HUMERAL STEM, AN AR-9502F-33CPC SUTURE CUP, AN AR-9503XS-03 HUMERAL INSERT, AN AR-9504-06 HUMERAL SPACER, AN AR-9562-24NL PERIPHERAL NON-LOCKING SCREW, AN AR-9563-16 PERIPHERAL LOCKING SCREW, AN AR-9563-20 PERIPHERAL LOCKING SCREW, AND AR-9563-24 PERIPHERAL LOCKING SCREW WERE EXPLANTED. THE CASE WAS COMPLETED BY TAKING CULTURES FOR FURTHER TESTING AND PLACING ANTIBIOTIC SPACERS. NO ADDITIONAL ARTHREX PRODUCTS WERE IMPLANTED.
Patient problems: Unspecified Infection
MAUDE report 17363965 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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