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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 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 92 92
Unintended System Motion 38 38
Device Handling Problem 23 23
Adverse Event Without Identified Device or Use Problem 12 12
Insufficient Information 11 11
Physical Resistance/Sticking 11 11
Fracture 2 2
Device Fell 1 1
Misassembled During Installation 1 1
Patient Device Interaction Problem 1 1
Crack 1 1
Electromagnetic Interference 1 1
Improper or Incorrect Procedure or Method 1 1
Component Missing 1 1
Fungus in Device Environment 1 1
Deformation Due to Compressive Stress 1 1
Contamination /Decontamination Problem 1 1
Detachment of Device or Device Component 1 1
Material Twisted/Bent 1 1
Mechanical Jam 1 1
Mechanics Altered 1 1
Moisture or Humidity Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Fall 87 87
No Consequences Or Impact To Patient 38 38
No Clinical Signs, Symptoms or Conditions 35 35
Bone Fracture(s) 27 27
Limb Fracture 24 24
No Known Impact Or Consequence To Patient 24 24
Hip Fracture 10 10
Fracture, Arm 7 7
Injury 7 7
Bruise/Contusion 6 6
Insufficient Information 6 6
Laceration(s) 5 5
Damage to Ligament(s) 5 5
Pain 3 3
Spinal Column Injury 3 3
Contusion 3 3
Concussion 2 2
Head Injury 2 2
Multiple Fractures 2 2
Intervertebral Disc Compression or Protrusion 1 1
Muscle/Tendon Damage 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
No Code Available 1 1
Hematoma 1 1
No Patient Involvement 1 1
Tissue Breakdown 1 1

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