Navio PFSR110018Recalls & reported problems
Smith & Nephew, Inc. · Navio Tibia Tracker Array · Class 2
All models of Navio (23)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556628546), received between Aug 17, 2022 and Aug 18, 2022 — classified as 2 injuries.
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
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, ON THE LITERATURE REVIEW "IS ROBOTIC-ASSISTED UNICOMPARTMENTAL KNEE ARTHROPLASTY A SAFE PROCEDURE? A CASE CONTROL STUDY", FOUR (4) UKA PROCEDURES ASSISTED WITH A BLUE BELT NAVIO ROBOTIC SURGICAL SYSTEM WERE ABORTED AND COMPLETED WITH CONVENTIONAL INSTRUMENTATION. ONE (1) OF THESE CASES WAS ABORTED BECAUSE THE TIBIAL TRACKING ARRAY WAS ACCIDENTALLY MOVED DURING SURGERY, MAKING THE REST OF THE SURGERY IMPOSSIBLE WITH THE ROBOTIC ASSISTED SYSTEM. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 15251912 ↗InjuryAug 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON THE LITERATURE REVIEW "THE SUCCESSFUL IMPLEMENTATION OF THE NAVIO ROBOTIC TECHNOLOGY REQUIRED 29 CASES", IT WAS REPORTED THAT ONE (1) PATIENT EXPERIENCED TIBIAL ARRAY DISPLACEMENT DURING A NAVIO-ASSISTED RA-TKA PROCEDURE. THIS EVENT WAS SOLVED BY CONVERTING THE PROCEDURE TO A MANUAL TKA. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15246078 ↗
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- 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 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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