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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
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

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 92 92
Unintended System Motion 44 44
Insufficient Information 16 16
Physical Resistance/Sticking 12 12
Device Handling Problem 8 8
Adverse Event Without Identified Device or Use Problem 7 7
Leak/Splash 1 1
Crack 1 1
Device Fell 1 1
Patient Device Interaction Problem 1 1
Misassembled During Installation 1 1
Component Missing 1 1
Material Twisted/Bent 1 1
Mechanics Altered 1 1
Material Deformation 1 1
Detachment of Device or Device Component 1 1
Fracture 1 1
Electromagnetic Interference 1 1
Improper or Incorrect Procedure or Method 1 1
Deformation Due to Compressive Stress 1 1
Mechanical Jam 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Fall 79 79
No Consequences Or Impact To Patient 37 37
No Clinical Signs, Symptoms or Conditions 35 35
Limb Fracture 28 28
No Known Impact Or Consequence To Patient 24 24
Bone Fracture(s) 21 21
Hip Fracture 11 11
Insufficient Information 8 8
Laceration(s) 6 6
Bruise/Contusion 6 6
Damage to Ligament(s) 5 5
Concussion 4 4
Fracture, Arm 3 3
Multiple Fractures 3 3
Spinal Column Injury 3 3
Injury 3 3
Pain 3 3
Tissue Breakdown 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
No Code Available 1 1
Head Injury 1 1
Muscle/Tendon Damage 1 1
Intervertebral Disc Compression or Protrusion 1 1

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