Arthrex® AR-9544-17RCARecalls & reported problems
Arthrex, Inc. · Revers CA Humeral Head, 44/17 · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867229471), received between Aug 18, 2021 and Aug 18, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Activation, Positioning or Separation 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 16, 2026.
Most reported problems
Device problems
- Activation, Positioning or Separation Problem1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 18, 2021Activation, Positioning or Separation Problem
ON (B)(6) 2021, IT WAS REPORTED BY SALES REPRESENTATIVE VIA PHONE THAT AR-9502-36ARCA REVERS 36MM CA ADAPTER ASSEMBLY (LINE #1) WOULD NOT ENGAGE WITH THE AR-9544-17RCA REVERS 36MM CA ADAPTER ASSEMBLY(LINE # 2) THE SURGEON COULD NOT ACHIEVE THE DESIRED STABILITY. A SECOND AR-9502-36ARCA (LINE #3) WAS OPENED AND THE SAME ISSUE OCCURRED. THE CASE WAS COMPLETED USING THE UNIVERSAL 2 STEM AND HEAD SYSTEM WITHOUT ISSUE. THE CASE WAS DELAYED 45 MINUTES. ADDITIONAL INFORMATION 8/2/2021: PER THE SALES REPRESENTATIVE, THE CASE WAS ON (B)(6). NO ADDITIONAL ANESTHESIA WAS REQUIRED TO COMPLETE THE CASE.
Patient problems: Insufficient Information
MAUDE report 12335670 ↗
Other PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED devices
- DJO SURGICAL 509-02-032Encore Medical, L.P. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED364 reports
- DELTA XTEND 130790036Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED171 reports
- DELTA XTEND 130770018Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED159 reports
- TRIGEN 71118200Smith & Nephew, Inc. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED123 reports
- DJO SURGICAL 509-02-432Encore Medical, L.P. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED119 reports
- DELTA XTEND 130738206Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED116 reports
- COMPREHENSIVE SHOULDER SYSTEM 113633Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED2 recalls4 reports
- DELTA XTEND 130742206Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED99 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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