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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device joint, knee, external limb component
Regulation Description External limb prosthetic component.
Product CodeISY
Regulation Number 890.3420
Device Class 1

MDR Year MDR Reports MDR Events
2020 80 80
2021 35 35
2022 23 23
2023 24 24
2024 14 14
2025 24 24

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 92 92
Unintended System Motion 55 55
Insufficient Information 24 24
Physical Resistance/Sticking 15 15
Device Handling Problem 8 8
Adverse Event Without Identified Device or Use Problem 7 7
Unintended Movement 3 3
Fracture 3 3
Leak/Splash 1 1
Crack 1 1
Device Fell 1 1
Patient Device Interaction Problem 1 1
Misassembled During Installation 1 1
Battery Problem 1 1
Component Missing 1 1
Material Twisted/Bent 1 1
Mechanics Altered 1 1
Material Deformation 1 1
Material Separation 1 1
Detachment of Device or Device Component 1 1
Electromagnetic Interference 1 1
Premature Discharge of Battery 1 1
Improper or Incorrect Procedure or Method 1 1
Deformation Due to Compressive Stress 1 1
Mechanical Jam 1 1
Intermittent Loss of Power 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Fall 98 98
No Clinical Signs, Symptoms or Conditions 37 37
No Consequences Or Impact To Patient 37 37
Limb Fracture 35 35
Bone Fracture(s) 25 25
No Known Impact Or Consequence To Patient 24 24
Hip Fracture 11 11
Insufficient Information 10 10
Bruise/Contusion 8 8
Laceration(s) 7 7
Damage to Ligament(s) 6 6
Pain 5 5
Spinal Column Injury 4 4
Concussion 4 4
Fracture, Arm 3 3
Multiple Fractures 3 3
Injury 3 3
Muscle/Tendon Damage 2 2
Tissue Breakdown 2 2
Skin Infection 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Arthralgia 1 1
No Code Available 1 1
Head Injury 1 1
Abrasion 1 1
Post Operative Wound Infection 1 1
Intervertebral Disc Compression or Protrusion 1 1

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