REAL INTELLIGENCE ROB10019Recalls & reported problems
Smith & Nephew, Inc. · REAL INTELLIGENCE TIBIA TRACKER · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556757383), received between Dec 11, 2023 and Dec 29, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Degraded” (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
- Degraded1
- Material Deformation1
- Positioning Problem1
- Unintended Movement1
- Unstable1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 29, 2025Unstable; Material Deformation; Unstable; Material Deformation
IT WAS REPORTED THAT BEFORE A TKA, A REAL INTELLIGENCE TIBIA TRACKER WAS NOTICED TO BE MOVING A BIT AND LOOKING PRETTY ROUNDED OFF. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23905748 ↗MalfunctionJun 6, 2025Degraded; Unintended Movement; Degraded; Unintended Movement
IT WAS REPORTED THAT DURING A CORI-ASSISTED TKA, THEY NOTICED THE REAL INTELLIGENCE TIBIA TRACKER HAVE WEAR AROUND WHERE THE CLAMPS TIGHTEN ON THE TRACKER FRAME. THEY WERE UNABLE TO COMPLETE TIBIA BONE REMOVAL BECAUSE OF THE MOVEMENT. SURGERY WAS PERFORMED AFTER A NON-SIGNIFICANT DELAY, WITH THE SAME DEVICES. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22159170 ↗MalfunctionDec 11, 2023Positioning Problem; Positioning Problem
IT WAS REPORTED THAT THE REAL INTELLIGENCE TIBIA TRACKER IS LOOSE AND NOT PROPERLY HELD BY THE TRACKER CLAMP. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18300639 ↗
Other Orthopedic stereotaxic instrument devices
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- NA 209063Mako Surgical Corp. · Orthopedic stereotaxic instrument2 recalls602 reports
- RESTORIS, RIO 212760Mako Surgical Corp. · Orthopedic stereotaxic instrument605 reports
- REAL INTELLIGENCE ROB10013Smith & Nephew, Inc. · Orthopedic stereotaxic instrument1 recall528 reports
- VELYS 4515-70-105Depuy (Ireland) · Orthopedic stereotaxic instrument578 reports
- VELYS 4515-70-106Depuy (Ireland) · Orthopedic stereotaxic instrument564 reports
- NA 209999Mako Surgical Corp. · Orthopedic stereotaxic instrument522 reports
- Mazor X System TPL0059-06Mazor Robotics Ltd · Orthopedic Stereotaxic Instrument2 recalls2 deaths392 reports
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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