Rheo Knee RKNXC0002Recalls & reported problems
Ossur Americas, Inc. · RHEO KNEE XC 2 YRS WARRANTY · Class 1
All models of Rheo Knee (8)
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 05690977467798), received between Oct 11, 2021 and Oct 11, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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
- Break1
Patient problems
- Fall1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 11, 2021Break
THE USER STEPPED DOWN FROM A TERRACE TO A MEADOW AND FELL, LEADING TO BROKEN FEMUR.
Patient problems: Fall
MAUDE report 12604533 ↗
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 RKNXC0003Ossur Americas, Inc. · Joint, Knee, External Limb Component1 recall3 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
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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