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Arthrex® AR-9349-20Recalls & reported problems

Arthrex, Inc. · ARTHREX ECLIPSE HUMERAL HEAD, 49/20 · Class 2 · Implant

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 00888867060074), received between Jun 21, 2023 and Jun 21, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Loosening of Implant Not Related to Bone-Ingrowth1

Patient problems

  • 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.

  • InjuryJun 21, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

    IT WAS REPORTED THAT A REVISION SHOULDER SURGERY WAS PERFORMED DUE TO LOOSENING AND ABRASION OF THE GLENOID COMPONENT. UPDATE AVOE 06-JUN-2023. IT WAS FURTHER REPORTED THAT THE INITIAL SURGERY TOOK PLACE IN 2015 AT THE (B)(6). DURING THE REVISION SURGERY ON (B)(6) 2023 THE PATIENT WAS TREATED WITH A CONVERSION TO AN INVERSE ASCEND FROM STRYKER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17170758 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.