Arthrex® AR-9300-43CPCRecalls & reported problems
Arthrex, Inc. · ECLIPSE TRUNION,43 MM TPS CTD · Class 2 · Implant
Data updated Oct 18, 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 00888867059863), received between Sep 20, 2024 and Sep 20, 2024 — classified as 1 injury.
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
Patient problems
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 20, 2024Break; Break
UPDATE DW 24-SEP-2024: FURTHER INFORMATION WAS PROVIDED THAT THE CUSTOMER HAS REMOVED THE GLENOID ARTHROSCOPIC. IT WAS THEN FURTHER REPORTED THAT DUE TO AN OMARTHROSE AN ADDITIONAL SURGERY WAS PERFORMED AND AN INVERSE SHOULDER-TEP WAS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 20266279 ↗
Other Total shoulder arthroplasty system devices
- Arthrex® AR-9301-03Arthrex, Inc. · Total shoulder arthroplasty system12 reports
- Arthrex® AR-9349-18Arthrex, Inc. · Total shoulder arthroplasty system9 reports
- Arthrex® AR-9301-01Arthrex, Inc. · Total shoulder arthroplasty system9 reports
- Arthrex® AR-9347-18Arthrex, Inc. · Total shoulder arthroplasty system7 reports
- Arthrex® AR-9343-16Arthrex, Inc. · Total shoulder arthroplasty system7 reports
- Arthrex® AR-9301-02Arthrex, Inc. · Total shoulder arthroplasty system6 reports
- Arthrex® AR-9345-17Arthrex, 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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