EVOLVE ORTHOLOC 4953105LRecalls & reported problems
Wright Medical Technology, Inc. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 00840420125798), received between Feb 17, 2026 and Feb 17, 2026 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Necrosis1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, THE PATIENT UNDERWENT A LEFT RADIAL HEAD REPLACEMENT FOR FRACTURE, APPROX. 2 AND HALF YEARS AGO, USING THE TORNIER MOPYC SYSTEM. PATIENT HAD PRESENTED TO THE SURGEON WITH PAIN, OVER LAST 4-6 MONTHS. ON X-RAY, IT SHOWED THE PROSTHETIC PYROCARBON HEAD RUBBING AGAINST A DISTAL HUMERAL PLATE, ALSO INSITU (IMPLANTED FOR AN ASSOCIATED FRACTURE OF THE DISTAL HUMERUS). DURING SURGERY, LARGE AMOUNTS OF BLACK COLOURED TISSUE WERE NOTED, AND AN EXTENSIVE DEBRIDEMENT AND LAVAGE WAS PERFORMED. MULTIPLE TISSUE SAMPLES TAKEN. THE ORIGINAL MOPYC STEM WAS FOUND TO BE SOLID AND THEREFORE LEFT INSITU. THE PRIMARY MOPYC NECK AND HEAD WAS REMOVED (WITHOUT DIFFICULTY) AND REPLACED WITH NEW PROSTHESIS. THE DISTAL HUMERAL PLATE, WHICH WAS RUBBING AGAINST THE PYC HEAD, WAS ALSO REMOVED (THE DISTAL HUMERAL FRACTURE WAS UNITED). THE ELBOW JOINT WAS FOUND TO BE STABLE ON REDUCTION. WOUND CLOSED.
Patient problems: Necrosis; Pain
MAUDE report 24365418 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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