Rheo Knee RKNXC230Recalls & reported problems
Ossur Americas, Inc. · RHEO KNEE XC TRIAL UNIT · 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 05690977467873), received between Jul 11, 2023 and Jul 17, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Inadequate User Interface” (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
- Inadequate User Interface1
- Insufficient Device Problem Information1
- Unintended Movement1
Patient problems
- Burn(s)1
- Hip Fracture1
- Limb Fracture1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 17, 2024Unintended Movement; Unintended Movement
THE USER WAS WALKING THROUGH THE KITCHEN WHEN THE KNEE BUCKLED, IN AN ATTEMPT TO STEADY HIMSELF, THE USER GRABBED THE HANDLE OF A HOT SAUCEPAN ON A STOVE, SPILLING BOILING WATER ON HIS RIGHT ARM AND SUSTAINING A SCALD. HE LANDED ON HIS LEFT HAND, FRACTURING HIS WRIST.
Patient problems: Burn(s); Limb Fracture
MAUDE report 19762084 ↗InjuryJul 11, 2023Inadequate User Interface; Insufficient Device Problem Information; Inadequate User Interface; Insufficient Device Problem Information
THE PATIENT WAS GETTING OUT OF BED WITH THE PROSTHETIC KNEE AND FELL. AS A RESULT OF THE FALL HE HAD A FEMORAL NECK FRACTURE.
Patient problems: Hip Fracture
MAUDE report 17297020 ↗
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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