VERASENSE VERASENSE for Smith & Nephew Journey II CR 5-6 RightRecalls & reported problems
Orthosensor Inc · Class 2
Data updated Oct 18, 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 00816818020761), received between Aug 31, 2020 and Aug 31, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Unintended Movement” (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
- Unintended Movement1
Patient problems
- Injury1
- Joint Disorder1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 31, 2020Unintended Movement; Unintended Movement
IT WAS REPORTED THAT, TWO YEARS AFTER A TKA HAD BEEN PERFORMED, THE PATIENT PRESENTED INSTABILITY ON THE RIGHT KNEE. THE ADVERSE EVENT WAS TREATED BY PERFORMING A REVISION SURGERY; THE JOURNEY II CR 5-6 RIGHT 10MM INSERT WAS REPLACED BY A JOURNEY II CR 5-6 RIGHT 12 MM. THE PATIENT OUTCOME IS UNKNOWN.
Patient problems: Injury; Joint Disorder
MAUDE report 10471572 ↗
Other Intraoperative Orthopedic Joint Assessment Aid devices
- VERASENSE VERASENSE for Zimmer Biomet Persona CR C-D/3-9 LeftOrthosensor Inc · Intraoperative Orthopedic Joint Assessment Aid1 recall0 reports
- VERASENSE VERASENSE for Zimmer Biomet Persona CR E-F/3-11 LeftOrthosensor Inc · Intraoperative Orthopedic Joint Assessment Aid1 recall0 reports
- VERASENSE VERASENSE for Zimmer Biomet Persona CR G-H/7-12 LeftOrthosensor Inc · Intraoperative Orthopedic Joint Assessment Aid1 recall0 reports
- VERASENSE VERASENSE for Zimmer Biomet Persona CR C-D/3-9 RightOrthosensor Inc · Intraoperative Orthopedic Joint Assessment Aid1 recall0 reports
- VERASENSE VERASENSE for Zimmer Biomet Persona CR G-H/7-12 RightOrthosensor Inc · Intraoperative Orthopedic Joint Assessment Aid1 recall0 reports
- VERASENSE VERASENSE for Zimmer Biomet Persona CR E-F/3-11 RightOrthosensor Inc · Intraoperative Orthopedic Joint Assessment Aid1 recall0 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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