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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


Premarket Reviews
ManufacturerDecision
RIZZOLI ORTOPEDICA S.P.A.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 2 2
2015 20 20
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 65 65
Device Handling Problem 40 40
Unintended System Motion 38 38
Adverse Event Without Identified Device or Use Problem 22 22
Insufficient Information 14 14
Physical Resistance/Sticking 11 11
Loose or Intermittent Connection 8 8
Device Slipped 7 7
Break 5 5
Component Missing 4 4
Failure To Service 2 2
Fracture 2 2
Crack 2 2
Improper or Incorrect Procedure or Method 2 2
Device Fell 1 1
Misassembled During Installation 1 1
Appropriate Term/Code Not Available 1 1
Patient Device Interaction Problem 1 1
Stretched 1 1
Use of Device Problem 1 1
Positioning Problem 1 1
Human Factors Issue 1 1
Human-Device Interface Problem 1 1
Material Twisted/Bent 1 1
Mechanical Jam 1 1
Mechanics Altered 1 1
Moisture or Humidity Problem 1 1
Disconnection 1 1
Electromagnetic Interference 1 1
Electrical /Electronic Property Problem 1 1
Bent 1 1
Component Falling 1 1
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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 132 132
Fall 120 120
Bone Fracture(s) 51 51
No Clinical Signs, Symptoms or Conditions 35 35
No Known Impact Or Consequence To Patient 32 32
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
Rupture 6 6
Insufficient Information 6 6
Spinal Column Injury 5 5
Pain 3 3
Hematoma 3 3
Contusion 3 3
Joint Dislocation 3 3
Multiple Fractures 2 2
No Code Available 2 2
Neck Pain 2 2
Skull Fracture 2 2
Abrasion 2 2
Tissue Damage 1 1
Physical Entrapment 1 1
Crushing Injury 1 1
Death 1 1
Hemorrhage/Bleeding 1 1
Intracranial Hemorrhage 1 1
No Patient Involvement 1 1
Tissue Breakdown 1 1
Intervertebral Disc Compression or Protrusion 1 1
Muscle/Tendon Damage 1 1
Loss of consciousness 1 1
Tooth Fracture 1 1
Spinal Cord Injury 1 1
Arthralgia 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Bock,Otto,Orthopedic Ind,Inc II Dec-16-2009
2 Ossur Engineering, Inc II Mar-25-2011
3 Ossur H / F II Feb-06-2012
4 Otto Bock Healthcare GmbH II Feb-01-2016
5 Otto Bock Healthcare GmbH II Jul-24-2015
6 Otto Bock Healthcare Product II Mar-01-2018
7 Ottobock Orthopedic Industrie II Feb-13-2019
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