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EVOLVE 496H222Recalls & reported problems

Wright Medical Technology, Inc. · 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 00840420185723), received between Jul 13, 2021 and Jul 13, 2021 — 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

  • Loss of Range of Motion1

Recent adverse event reports

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

  • InjuryJul 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RADIAL HEAD REPLACEMENT OPERATION. IT IS ALLEGED THAT THE SURGEON WENT OVER THE PROCEDURE PRIOR TO SURGERY AND WAS GOING TO PERFORM A LEFT RADIAL HEAD FRACTURE PROCEDURE HOWEVER DURING THE PROCEDURE CHANGED TO A LEFT RADIUS HEAD REPLACEMENT. IT IS ALSO ALLEGED THAT AFTER THE OPERATION, THE SURGEON DID NOT TELL THE PATIENT HOW TO EFFECTIVELY CONDUCT REHABILITATION TRAINING, AND THE PATIENT'S ELBOW COULD NOT RETURN TO NORMAL FUNCTION. THE PATIENT WAS NOT SATISFIED WITH THE RESULTS WITH FLEXION AND EXTENSION.

    Patient problems: Loss of Range of Motion

    MAUDE report 12163324 ↗

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.