Power Knee PKA10003Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05690967648749), received between Sep 28, 2026 and Sep 28, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

2 FDA recall records name this device's identifier, 2 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Dec 26, 2023Open, Classified

   Knee batteries may need replacement with conforming batteries to ensure there isn't a failure to turn on the device, or an unexpected shutdown, which is a momentary loss of power to the knee where the user may experience loss of support that can lead to a fall and potential injury.

   Z-0788-2024 · Root cause: Process control · FDA record ↗

2. Aug 29, 2022Open, Classified

   Battery may dislodge from the Power Knee

   Z-1821-2022 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Insufficient Device Problem Information

  Patient was walking outside his apartment complex, fell on the sidewalk, hit his head on the bricks behind him, and lost consciousness.

  Patient problems: Concussion

  MAUDE report 50916668 ↗