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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
2021 35 35
2022 23 23
2023 24 24
2024 14 14
2025 28 28
2026 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended System Motion 59 59
Mechanical Problem 31 31
Insufficient Information 23 23
Physical Resistance/Sticking 14 14
Adverse Event Without Identified Device or Use Problem 4 4
Unintended Movement 3 3
Fracture 2 2
Premature Discharge of Battery 2 2
Leak/Splash 1 1
Misassembled During Installation 1 1
Battery Problem 1 1
Material Deformation 1 1
Material Separation 1 1
Electromagnetic Interference 1 1
Improper or Incorrect Procedure or Method 1 1
Intermittent Loss of Power 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Fall 85 85
Limb Fracture 34 34
No Clinical Signs, Symptoms or Conditions 33 33
Bone Fracture(s) 16 16
Hip Fracture 11 11
Insufficient Information 11 11
Bruise/Contusion 9 9
Laceration(s) 8 8
Damage to Ligament(s) 5 5
Multiple Fractures 3 3
Concussion 3 3
Pain 3 3
Spinal Column Injury 2 2
Muscle/Tendon Damage 2 2
Tissue Breakdown 2 2
Skin Infection 1 1
Arthralgia 1 1
Inadequate Osseointegration 1 1
Skull Fracture 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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