Rheo Knee RKN130005Recalls & reported problems
Ossur Americas, Inc. · RHEO KNEE 5Y INC 40M SVC · Class 1
All models of Rheo Knee (8)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05690967598433), received between May 5, 2021 and Oct 22, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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
- Adverse Event Without Identified Device or Use Problem2
- Insufficient Device Problem Information1
Patient problems
- Fall1
- Limb Fracture1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 22, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
ACCORDING TO THE USER THE PROSTHETIC KNEE UNEXPECTEDLY GAVE WAY WHILE THE USER WAS WALKING IN THEIR LIVING ROOM. AS A RESULT, THE USER FELL AND BROKE THEIR FEMUR. THE USER REQUIRED MEDICAL ATTENTION AND HAS BEEN HOSPITALISED.
Patient problems: Limb Fracture
MAUDE report 23356135 ↗InjuryMay 5, 2021Adverse Event Without Identified Device or Use Problem
PATIENT FELL AS HE STEPPED BACKWARDS FROM MULCH ONTO HIS DRIVEWAY. THE PATIENT SUFFERED A FRACTURE TO THE FEMUR WHICH REQUIRED SCREWS. PATIENT IS RECOVERING WELL.
Patient problems: Fall
MAUDE report 11777646 ↗
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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