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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
2016 49 49
2017 87 87
2018 34 34
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 164 164
Device Operates Differently Than Expected 62 62
Device Handling Problem 39 39
Unintended System Motion 38 38
Adverse Event Without Identified Device or Use Problem 22 22
Insufficient Information 13 13
Physical Resistance/Sticking 11 11
Component Missing 4 4
Loose or Intermittent Connection 3 3
Break 3 3
Failure To Service 2 2
Fracture 2 2
Improper or Incorrect Procedure or Method 2 2
Device Maintenance Issue 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
Device Slipped 1 1
Stretched 1 1
Use of Device Problem 1 1
Crack 1 1
Electromagnetic Interference 1 1
Electrical /Electronic Property Problem 1 1
Device Fell 1 1
Misassembled During Installation 1 1
Patient Device Interaction Problem 1 1
Human Factors Issue 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
No Consequences Or Impact To Patient 123 123
Fall 111 111
Bone Fracture(s) 51 51
No Clinical Signs, Symptoms or Conditions 35 35
No Known Impact Or Consequence To Patient 29 29
Limb Fracture 24 24
Injury 18 18
Hip Fracture 17 17
Fracture, Arm 14 14
Bruise/Contusion 13 13
Head Injury 8 8
Damage to Ligament(s) 8 8
Concussion 8 8
Laceration(s) 7 7
Insufficient Information 6 6
Rupture 6 6
Spinal Column Injury 5 5
Pain 3 3
Contusion 3 3
Hematoma 3 3
Joint Dislocation 3 3
No Code Available 2 2
Multiple Fractures 2 2
Abrasion 2 2
Skull Fracture 2 2
Arthralgia 1 1
Death 1 1
Intracranial Hemorrhage 1 1
Intervertebral Disc Compression or Protrusion 1 1
Muscle/Tendon Damage 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
Tissue Breakdown 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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