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EVOLVE 496H022Recalls & reported problems

Wright Medical Technology, Inc. · Class 2 · Implant

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 00840420126061), received between Jul 18, 2023 and Jul 18, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Component Missing” (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

  • Component Missing1
  • Inaccurate Information1
  • Inadequacy of Device Shape and/or Size1

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.

  • MalfunctionJul 18, 2023Inadequacy of Device Shape and/or Size; Component Missing; Inaccurate Information; Inadequacy of Device Shape and/or Size; Component Missing; Inaccurate Information

    ACCORDING TO THE REPORT, A PACKING ERROR WAS IDENTIFIED WHEREBY AN INCORRECT IMPLANT SIZE WAS ERRONEOUSLY PACKAGED WITH LABELING INCONSISTENT WITH ITS ACTUAL SIZE. AS A CONSEQUENCE, A SURGICAL DELAY OF APPROXIMATELY 15-20 MINUTES OCCURRED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17347306 ↗

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.