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RHEAD RHA-H2Recalls & reported problems

Stryker GmbH · Radial head implant , Size 2 · 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 00886385024660), received between Mar 27, 2019 and Mar 27, 2019 — classified as 1 injury.

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

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • No Code Available1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryMar 27, 2019Adverse Event Without Identified Device or Use Problem

    DUE TO THE ALERT SENT OUT BY MHRA DOCTOR REVIEW THE PATIENT WHO HAD AN RHEAD IMPLANTED TWO YEARS AGO THE PATIENT IN QUESTION HAD PRIMARY SURGERY FOR A FRACTURE, HAS NOT BEEN REVISED, HER ACTIVITY LEVEL IS MEDIUM. THERE IS BONE RESORPTION AROUND THE HEAD OF THE RADIAL HEAD IMPLANT BUT NOT AROUND THE IMPLANT STEM.

    Patient problems: No Code Available

    MAUDE report 8457269 ↗

Other PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER devices

All PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER devices →

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