Rheo Knee RKNXC0003Recalls & reported problems
Ossur Americas, Inc. · RHEO KNEE XC 3 YRS WARRANTY · Class 1
All models of Rheo Knee (8)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05690977467804), received between Feb 8, 2022 and Aug 8, 2025 — classified as 3 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Mar 25, 2024Class IIOpen, Classified
Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls.
Z-1789-2024 · Root cause: Software design · Recall details · FDA record ↗
Most reported problems
Device problems
- Insufficient Device Problem Information2
- Break1
- Human-Device Interface Problem1
- Intermittent Loss of Power1
Patient problems
- Damage to Ligament(s)1
- Fall1
- Limb Fracture1
- Muscle/Tendon Damage1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryAug 8, 2025Insufficient Device Problem Information; Intermittent Loss of Power; Insufficient Device Problem Information; Intermittent Loss of Power
USER FELL AND BROKE A FINGER WHEN BREAKING THE FALL.
Patient problems: Limb Fracture
MAUDE report 22747264 ↗InjuryAug 13, 2024Human-Device Interface Problem; Insufficient Device Problem Information; Human-Device Interface Problem; Insufficient Device Problem Information
PATIENT TRIPPED OVER PAVING STONES AND HURT HIS SHOULDER. PATIENT INDICATES THAT IT IS NOT CLEAR WHETHER THE TRIPPING WAS DUE TO KNEE MALFUNCTION OR IF HE JUST TRIPPED HIMSELF. AN MRI SCAN INDICATED THAT ROTATOR CUP OF PATIENT'S RIGHT SHOULDER IS TORN (UPPER TENDON TO LIFT ARM). THE SHOULDER WAS OPERATED AND PATIENT WILL FULLY RECOVER.
Patient problems: Damage to Ligament(s); Muscle/Tendon Damage
MAUDE report 19972545 ↗InjuryFeb 8, 2022Break
THE PATIENT WAS WALKING IN THE KITCHEN, TOOK A HARD FALL AND BROKE HER ANKLE. SHE BELIEVES THE KNEE FELT AS THOUGH IT LOCKED UP BUT WAS NOT SURE BECAUSE IT HAPPENED SO FAST.
Patient problems: Fall
MAUDE report 13480477 ↗
Other Joint, Knee, External Limb Component devices
- Power Knee PKA10003Ossur Americas, Inc. · Joint, Knee, External Limb Component2 recalls1 report
- Power Knee PKA10001Ossur Americas, Inc. · Joint, Knee, External Limb Component2 recalls0 reports
- Rheo Knee RKN130003Ossur Americas, Inc. · Joint, Knee, External Limb Component1 recall5 reports
- Rheo Knee RKNXC0005Ossur Americas, Inc. · Joint, Knee, External Limb Component1 recall1 report
- Rheo Knee RKN130002Ossur Americas, Inc. · Joint, Knee, External Limb Component1 recall0 reports
- Power Knee PKA01001LOssur Americas, Inc. · Joint, Knee, External Limb Component1 recall0 reports
- Power Knee PKA10002Ossur Americas, Inc. · Joint, Knee, External Limb Component1 recall0 reports
- Power Knee PKA01001TOssur Americas, Inc. · Joint, Knee, External Limb Component1 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 · each recall links to the FDA recall notice
- 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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