# Codebook: FDA reports on lower-limb prostheses (knees, feet, sockets and other leg components)

Written before any report in the set was coded. Mobility Atlas study, October 2026.

## Pool
Every FDA MAUDE device report with text filed under product code ISY (Joint, Knee, External Limb Component), ISH (Component, External, Limb, Ankle/Foot), ISW (Assembly, Knee/Shank/Ankle/Foot, External), ISS (Prosthesis, Thigh Socket, External Component), ISP (Valve, Prosthesis), ISL (Joint, Hip, External Limb Component) or KFX (Assembly, Thigh/Knee/Shank/Ankle/Foot, External), received at any date up to the latest openFDA update read on 18 October 2026.

## What you record for each report
One line per report: `report_key,device,part,mode,injury,fall,user,finding,note`

### DEVICE (one letter): the kind of product the report is about (text first, then the brand in the header).
- M: MICROPROCESSOR OR POWERED KNEE (C-Leg, Genium, X3, Kenevo, Rheo, Power Knee, Orion, Plié, Allux, any knee with a battery, sensors or software).
- K: NON-MICROPROCESSOR KNEE (mechanical, hydraulic or pneumatic knee with no battery).
- P: POWERED OR MICROPROCESSOR ANKLE-FOOT (Empower, Meridium, Proprio, Elan, Triton smart ankle, any foot with a battery).
- F: NON-POWERED FOOT OR ANKLE (carbon, energy-storing, multiaxial, SACH, Pro-Flex, Taleo, Triton, any foot with no battery).
- S: SOCKET, LINER, SUSPENSION OR VALVE (socket, liner, sleeve, lock, pin, vacuum pump, expulsion valve).
- H: HIP JOINT.
- C: ANOTHER LEG COMPONENT (pylon, tube adapter, torsion or shock unit, rotator, connector) when no knee or foot is the subject.
- U: a leg prosthesis, but the kind cannot be told.
- O: another device (an arm prosthesis, an orthosis, a wheelchair).
- N: no event (blank or administrative).

### PART (one letter): the part the report says failed FIRST (code the allegation even if the maker found no fault).
- B: BATTERY, CHARGER, CABLE OR POWER (would not charge, battery ran down early, swelled, charger failed).
- E: ELECTRONICS OR SOFTWARE (sensor, board, firmware, app, error code, mode switching, Bluetooth, unexpected switch of mode, alarms, vibration warnings).
- Y: HYDRAULIC OR PNEUMATIC UNIT (cylinder, damper, leaking oil, loss of resistance).
- J: JOINT OR AXIS (knee axle, bearing, joint bolt, link, the knee or ankle joint itself) mechanical failure.
- K: KEEL, FOOT PLATE OR FOOT SHELL (carbon keel, heel, toe spring, foot cover, sole).
- P: PYLON, TUBE, ADAPTER OR CONNECTOR (tube clamp, pyramid adapter, screw that joins components).
- S: SOCKET, LINER, LOCK OR VALVE.
- W: HARDWARE: a screw, bolt or set screw not tied to one of the parts above.
- Q: a device problem is alleged but no part is named.
- X: an event is described but nothing failed (fall while the device worked, fit or training issue, skin problem with no device fault).
- N: no event.

### MODE (one letter): how it failed
- K: broke, cracked, snapped, fractured, delaminated.
- L: loose, came apart, separated, came off.
- G: GAVE WAY: the knee buckled, flexed unexpectedly, lost stance resistance, locked or did not lock, collapsed under the user (use for knees and for any component that "gave way").
- E: stopped working, switched off, error, would not charge or connect, noise or vibration warning.
- W: worn, leaking, torn.
- O: other or not stated. Use O for PART Q, X and N.

### FLAGS (y or n)
- injury: harm to the body or medical care is stated (bruise, cut, fracture, stitches, hospital, death; pain alone counts). y when the event type is Death.
- fall: the user fell or went to the ground.
- user: the report says the user or a third party caused it (misuse, wrong setting, alignment by a prosthetist, water, overload, a non-approved part, lack of service), as the cause or the maker's conclusion.

### FINDING (one letter): what the maker found
- D: a fault was found or confirmed, or a part was replaced because it was faulty.
- N: no fault found, worked as designed, or the cause was outside the device.
- X: not evaluated, not returned, or nothing stated.

### note
At most 15 words: device, part, what made it hard. No quotes longer than 6 words. No personal details.

## Output format
CSV with header `report_key,device,part,mode,injury,fall,user,finding,note`, one row per report, nothing else.