EVOLVE 496H018Recalls & 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 00840420126047), received between Jul 8, 2024 and Jul 8, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Loss of Osseointegration” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Loss of Osseointegration1
Patient problems
- Inadequate Osseointegration1
- Osteolysis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 8, 2024Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem; Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD A LOOSENING LINE ABOUT 10 MONTHS POST-OP. 2 YEARS POST-OP THE BONE RESORPTION SEEMS TO BE PROGRESSING, AND THERE IS A GAP VISIBLE BETWEEN THE OSTEOTOMY SURFACE AND THE STEM. THE PATIENT HAS NO COMPLAINTS AND IS UNDER OBSERVATION.
Patient problems: Inadequate Osseointegration; Osteolysis
MAUDE report 19697295 ↗
Other PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER devices
- EVOLVE 496S275Wright Medical Technology, Inc. · PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER1 recall6 reports
- NA 09.405.966SSynthes GmbH · PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER1 recall2 reports
- NA 03.405.000SSynthes GmbH · PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER1 recall2 reports
- NA 09.405.250SSynthes GmbH · PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER1 recall1 report
- NA 09.405.263SSynthes GmbH · PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER1 recall1 report
- NA 09.405.570SSynthes GmbH · PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER1 recall1 report
- EXPLOR 11-210061Biomet Orthopedics, LLC · PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER1 recall1 report
- NA 09.405.583SSynthes GmbH · PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER1 recall1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.