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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
2016 49 49
2017 87 87
2018 34 34
2019 22 22
2020 80 80
2021 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 141 141
Device Operates Differently Than Expected 62 62
Device Handling Problem 39 39
Adverse Event Without Identified Device or Use Problem 20 20
Component Missing 4 4
Screw 4 4
Break 3 3
Insufficient Information 3 3
Loose or Intermittent Connection 3 3
Unintended System Motion 3 3
Failure To Service 2 2
Physical Resistance/Sticking 2 2
Fracture 2 2
Bolt 2 2
Heads 1 1
Bearings 1 1
Device Slipped 1 1
Stretched 1 1
Use of Device Problem 1 1
Crack 1 1
Deformation Due to Compressive Stress 1 1
Detachment of Device or Device Component 1 1
Human Factors Issue 1 1
Material Twisted/Bent 1 1
Mechanical Jam 1 1
Thread 1 1
Patient Device Interaction Problem 1 1
Device Fell 1 1
Device Maintenance Issue 1 1
Improper or Incorrect Procedure or Method 1 1
Fungus in Device Environment 1 1
Contamination /Decontamination Problem 1 1
Mechanics Altered 1 1
Moisture or Humidity Problem 1 1
Electrical /Electronic Property Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 123 123
Fall 63 63
Bone Fracture(s) 42 42
No Known Impact Or Consequence To Patient 29 29
Injury 18 18
Fracture, Arm 14 14
No Clinical Signs, Symptoms or Conditions 12 12
Hip Fracture 9 9
Bruise/Contusion 8 8
Concussion 8 8
Head Injury 7 7
Rupture 6 6
Laceration(s) 5 5
Damage to Ligament(s) 4 4
Spinal Column Injury 4 4
Contusion 3 3
Hematoma 3 3
Joint Dislocation 3 3
No Code Available 2 2
Limb Fracture 2 2
Pain 2 2
Skull Fracture 2 2
Abrasion 2 2
Death 1 1
Intracranial Hemorrhage 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Loss of consciousness 1 1
Tooth Fracture 1 1
Spinal Cord Injury 1 1
Neck Pain 1 1
No Patient Involvement 1 1
Arthralgia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Otto Bock Healthcare GmbH II Feb-01-2016
2 Otto Bock Healthcare Product II Mar-01-2018
3 Ottobock Orthopedic Industrie II Feb-13-2019
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