NextAR TKA Platform 02.23.10.0011Recalls & reported problems
Medacta International SA · NextAR infrared camera · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 07630971267558), received between Sep 10, 2021 and Sep 10, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Computer Software Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Computer Software Problem1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 10, 2021Computer Software Problem; Computer Software Problem
DURING SURGERY THERE WAS SOME ISSUES WITH THE SYSTEM WHICH LED THE SURGEON TO USE A REVISION SYSTEM INSTEAD OF THE PROGRAMMED PRIMARY KNEE. THE MAIN PROBLEMS HAPPENED DURING THE FEMUR PREPARATION.
Patient problems: Insufficient Information
MAUDE report 12451988 ↗
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- XVS Headset IPD-60 Clear Display AHMD601WLTAugmedics Ltd · Orthopedic Augmented Reality4 reports
- XVS Straight Clamp AMCH00005Augmedics Ltd · Orthopedic Augmented Reality3 reports
- NextAR Spine Platform 03.57.10.0026Medacta International SA · Orthopedic Augmented Reality2 reports
- NextAR Spine Platform 03.57.10.0173Medacta International SA · Orthopedic Augmented Reality2 reports
- MyKnee NextAR Tibial Distal Cutting Block Efficiency 15.1242Medacta International SA · Orthopedic Augmented Reality1 report
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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