Arthrex® AR-9301-51CPCRecalls & reported problems
Arthrex, Inc. · ECLIPSE TRUNION 51MM, SLOTTED, TPS CaP · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867276185), received between Feb 9, 2023 and Feb 9, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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
- Device Dislodged or Dislocated1
- Device-Device Incompatibility1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 9, 2023Device-Device Incompatibility; Device Dislodged or Dislocated; Device Dislodged or Dislocated
ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT WHILE USING AN AR-9301-03 ARTHREX ECLIPSE CAGE SCREW LARGE, AN AR-9400-SBK ECLIPS SPEEDSCAP IMPLANT SYSTEM AND AN AR-9301-51CPC ECLIPSE TRUNION, DURING THE FINAL STEPS, THE SURGEON DRILLED THE PILOT HOLE INTO THE SCREW AND FIXATION WAS COMPROMISED. SURGEON MOVED TO AN APEX SYSTEM INSTEAD. WHILE USING THE APEX, FIXATION WAS ALSO COMPROMISED WHEN TRAILING THE HEAD, SO SURGEON USED A LARGER SIZE INSTEAD. ADDITIONAL INFORMATION REQUESTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 16341476 ↗
Other Total shoulder arthroplasty system devices
- Arthrex® AR-9301-03Arthrex, Inc. · Total shoulder arthroplasty system12 reports
- Arthrex® AR-9301-01Arthrex, Inc. · Total shoulder arthroplasty system9 reports
- Arthrex® AR-9349-18Arthrex, Inc. · Total shoulder arthroplasty system9 reports
- Arthrex® AR-9343-16Arthrex, Inc. · Total shoulder arthroplasty system7 reports
- Arthrex® AR-9347-18Arthrex, Inc. · Total shoulder arthroplasty system7 reports
- Arthrex® AR-9345-17Arthrex, Inc. · Total shoulder arthroplasty system6 reports
- Arthrex® AR-9301-02Arthrex, Inc. · Total shoulder arthroplasty system6 reports
- Arthrex® AR-9341-16Arthrex, Inc. · Total shoulder arthroplasty system5 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.
How reports and recalls are matched · Editorial policy · Report an error on this page