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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
2019 22 22
2020 80 80
2021 35 35
2022 23 23
2023 24 24
2024 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 92 92
Unintended System Motion 41 41
Device Handling Problem 23 23
Insufficient Information 13 13
Adverse Event Without Identified Device or Use Problem 12 12
Physical Resistance/Sticking 11 11
Fracture 2 2
Leak/Splash 1 1
Crack 1 1
Device Fell 1 1
Moisture or Humidity Problem 1 1
Mechanics Altered 1 1
Material Deformation 1 1
Electromagnetic Interference 1 1
Fungus in Device Environment 1 1
Detachment of Device or Device Component 1 1
Contamination /Decontamination Problem 1 1
Misassembled During Installation 1 1
Patient Device Interaction Problem 1 1
Material Twisted/Bent 1 1
Component Missing 1 1
Improper or Incorrect Procedure or Method 1 1
Mechanical Jam 1 1
Deformation Due to Compressive Stress 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Fall 92 92
No Consequences Or Impact To Patient 38 38
No Clinical Signs, Symptoms or Conditions 35 35
Bone Fracture(s) 28 28
No Known Impact Or Consequence To Patient 24 24
Limb Fracture 24 24
Hip Fracture 11 11
Insufficient Information 8 8
Fracture, Arm 7 7
Injury 7 7
Bruise/Contusion 7 7
Laceration(s) 6 6
Damage to Ligament(s) 5 5
Concussion 4 4
Contusion 3 3
Spinal Column Injury 3 3
Pain 3 3
Head Injury 2 2
Multiple Fractures 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
No Code Available 1 1
Hematoma 1 1
No Patient Involvement 1 1
Muscle/Tendon Damage 1 1
Intervertebral Disc Compression or Protrusion 1 1
Tissue Breakdown 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ottobock Orthopedic Industrie II Feb-13-2019
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