Aura APKA 150Recalls & reported problems
College Park Industries, Inc. · Aura Polycentric Knee Assembly · Class 1
- 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 00841747186707), received between Mar 17, 2026 and Mar 17, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Mechanical Problem” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Mechanical Problem1
Patient problems
- Bone Fracture(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 17, 2026Mechanical Problem
THE USER PUT ON THE SHOWER LEG IN A SEATED POSITION, AS SHE DOES EVERY MORNING, AND SET THE KNEE JOINT TO "LOCK" SO THAT WHEN SHE STANDS UP, THE LEG IS FIXED AND DOES NOT BEND AGAIN. HOWEVER, THE LOCKING MECHANISM DID NOT ENGAGE. AS A RESULT, THE LEG BENT/COLLAPSED DESPITE BEING SET TO "LOCK," AND THE CUSTOMER FELL. SHE SPENT FIVE DAYS IN THE HOSPITAL. THE INJURIES INVOLVED THE RIBS AND LUMBAR VERTEBRAE. DUE TO THE PATIENT'S HEALTH CONDITION, SURGERY WAS NOT PERFORMED. INSTEAD, SHE RECEIVED CONSERVATIVE TREATMENT AND PAIN THERAPY.
Patient problems: Bone Fracture(s)
MAUDE report 24619992 ↗
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- Rheo Knee RKNXC0005Ossur Americas, Inc. · Joint, Knee, External Limb Component1 recall1 report
- Power Knee PKA01001TOssur Americas, Inc. · Joint, Knee, External Limb Component1 recall0 reports
- Rheo Knee RKN130002Ossur Americas, Inc. · Joint, Knee, External Limb Component1 recall0 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.