Rheo Knee RKNXC0005Recalls & reported problems
Ossur Americas, Inc. · RHEO KNEE XC 5YWARR incl 40MSC · 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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05690977467811), received between Jan 16, 2019 and Jan 16, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Defective Device” (1 report).
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.
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-1790-2024 · Root cause: Software design · Recall details · FDA record ↗
Most reported problems
Device problems
- Defective Device1
Patient problems
- Bone Fracture(s)1
- Fall1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 16, 2019Defective Device
KNEE IS FAILING TO LOCK WHEN WEIGHT ACTIVATED, PATIENT FELL AND HAS BROKEN HIS FEMUR ON AMPUTATED SIDE.
Patient problems: Bone Fracture(s); Fall
MAUDE report 8252100 ↗
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 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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