Motive Knee System OT01-1002Recalls & reported problems
Motive Health, Inc. · MOTIVE KNEE SYSTEM, RIGHT & LEFT, STANDARD · 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 00850022650345), received between Mar 7, 2024 and Mar 7, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Use of Device 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.
Reports received per month
Most reported problems
Device problems
- Use of Device Problem1
Patient problems
- Superficial (First Degree) Burn1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 7, 2024Use of Device Problem; Use of Device Problem
ON (B)(6) 2024, THE CUSTOMER CONTACTED MOTIVE CUSTOMER SERVICE STATING THAT HE USED THE MOTIVE DEVICE TO TREAT HIS RIGHT KNEE. AFTER THE SECOND TREATMENT, THE CUSTOMER NOTICED SOME GEL PULLED AWAY FROM THE PAD AND STAYED ON HIS LEG; EACH TREATMENT THEREAFTER THE GEL DEGRADED FURTHER. THE PAD READ 68% OF USAGE ON THE APP AND THE CUSTOMER FOUND TWO BURN MARKS ON HIS LEG. IT WAS REPORTED BY THE CUSTOMER THAT ONE OF THE BURNS WAS DEEP. THS CUSTOMER HAD COMPLETED 6 TREATMENTS: 10 MIN (1); 30 MINUTES (2), 30 MINUTES (3); 30 MINUTES (4); 30 MINUTES (5); 30 MINUTES (6). INITIALLY THE CUSTOMER USED A DIME SIZE ABOUT OF ELECTRODE GEL ON HIS LEG BEFORE TREATEMENT; HOWEVER, THE TREATMENT DISCOMFORT PROMPTED HIM TO INCREASE THE AMOUNT TO ELECTRODE GEL THAT WAS USED ON HIS LEG BEFORE TREATMENT.
Patient problems: Superficial (First Degree) Burn
MAUDE report 18861530 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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