Arthrex® AR-9503XS-03CRecalls & reported problems
Arthrex, Inc. · Humeral Insert XS 33+3mm Constrained · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867406865), received between Mar 20, 2024 and May 28, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break1
- Inadequacy of Device Shape and/or Size1
Patient problems
- Insufficient Information2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 28, 2025Break; Break
ON 04/29/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-9503XS-03C UNIVERS REVERS MODULAR GLENOID SYSTEM POLY, LOCATED ON THE HUMERAL SIDE OF A REVERSE SHOULDER IMPLANT, EXHIBITED WEAR AND CRACKING DURING USE. A FRAGMENT BROKE OFF AND FELL INSIDE THE PATIENT AND WAS RETRIEVED. THE CASE REPORT NOTED EXPOSURE TO BODILY FLUID AND INFECTION. THE CASE WAS COMPLETED, AND NO ADDITIONAL DETAILS WERE PROVIDED. THIS WAS DISCOVERED DURING A REVERSE TOTAL SHOULDER ARTHROPLASTY PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22095559 ↗MalfunctionMar 20, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
ON 03/05/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT AN AR-9502F-33LCPC UNIVERS REVERS SUTURE CUP, AR-9503XS-03C HUMERAL INSERT, AND AN AR-9501-05P UNIVERS REVERS¿ HUMERAL STEM FAILED IN A CASE. THIS OCCURRED DURING A REVERS TOTAL SHOULDER PROCEDURE ON (B)(6) 2024 WHEN THE SURGEON DECIDED TO CHANGE THE POLY SIZE WHEN TRYING TO EXTRACT THE IMPLANT. THE REST OF THE CONSTRUCT BECAME LOOSE. THEY THEN HAD TO EXCHANGE FOR A BIGGER STEM, A NEW SUTURE CUP, AND THE CORRECTLY SIZED POLY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 18943693 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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