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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
Definition This type of device is designed to allow for motion between the plastic tibial bearing and metal tibial baseplate components of a unicompartmental knee prosthesis. It is intended to replace part of a knee joint in order to relieve pain and restore knee function, for indications such as osteoarthritis and avascular necrosis.
Product CodeNRA
Device Class 3

Premarket Approvals (PMA)
2016 2017 2018 2019 2020 2021
6 8 14 12 2 0

MDR Year MDR Reports MDR Events
2016 531 531
2017 676 676
2018 251 251
2019 518 518
2020 190 190
2021 48 48

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 1087 1087
Appropriate Term/Code Not Available 208 208
Adverse Event Without Identified Device or Use Problem 191 191
Device Dislodged or Dislocated 154 154
Migration or Expulsion of Device 152 152
Fracture 83 83
Loose or Intermittent Connection 83 83
Unstable 57 57
Break 46 46
Patient Device Interaction Problem 34 34
Mechanical Problem 32 32
Loss of or Failure to Bond 28 28
Material Integrity Problem 25 25
Noise, Audible 22 22
Loosening of Implant Not Related to Bone-Ingrowth 20 20
Migration 19 19
Malposition of Device 18 18
Unintended Movement 16 16
Packaging Problem 14 14
Material Erosion 12 12
Naturally Worn 11 11
Manufacturing, Packaging or Shipping Problem 10 10
Detachment Of Device Component 8 8
Inadequacy of Device Shape and/or Size 7 7
Tear, Rip or Hole in Device Packaging 7 7
Device Markings/Labelling Problem 6 6
Metal Shedding Debris 6 6
Collapse 6 6
Unsealed Device Packaging 5 5
Off-Label Use 4 4
Detachment of Device or Device Component 4 4
Device Packaging Compromised 4 4
Fitting Problem 4 4
Device-Device Incompatibility 3 3
Failure To Adhere Or Bond 3 3
Delivered as Unsterile Product 3 3
Missing Information 3 3
Difficult to Open or Remove Packaging Material 3 3
Material Twisted/Bent 3 3
Use of Device Problem 3 3
No Device Output 3 3
Disassembly 3 3
Material Fragmentation 3 3
Component Incompatible 2 2
Degraded 2 2
Problem with Sterilization 2 2
Mechanical Jam 2 2
Device Operates Differently Than Expected 2 2
Patient-Device Incompatibility 2 2
Inaccurate Delivery 2 2
Scratched Material 2 2
Device Appears to Trigger Rejection 2 2
Component Falling 2 2
Entrapment of Device 2 2
Device Contamination with Chemical or Other Material 2 2
Sticking 1 1
Device Inoperable 1 1
Material Rupture 1 1
Product Quality Problem 1 1
Dull, Blunt 1 1
Structural Problem 1 1
Failure to Osseointegrate 1 1
Component Missing 1 1
Deformation Due to Compressive Stress 1 1
No Apparent Adverse Event 1 1
Shipping Damage or Problem 1 1
Device Slipped 1 1
Pitted 1 1
Inadequate Instructions for Healthcare Professional 1 1
Device Handling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Information 776 776
Pain 662 662
No Code Available 197 197
Joint Dislocation 136 136
Bone Fracture(s) 109 109
Swelling 89 89
No Known Impact Or Consequence To Patient 81 81
Unspecified Infection 77 77
Ambulation Difficulties 69 69
Death 55 55
Arthritis 45 45
No Consequences Or Impact To Patient 43 43
Loss of Range of Motion 37 37
Limited Mobility Of The Implanted Joint 29 29
Insufficient Information 26 26
Fall 21 21
Synovitis 21 21
Edema 20 20
Patient Problem/Medical Problem 20 20
No Patient Involvement 17 17
Reaction 16 16
Damage to Ligament(s) 14 14
Sleep Dysfunction 13 13
Failure of Implant 12 12
Discomfort 11 11
Joint Swelling 11 11
Necrosis 10 10
Inflammation 10 10
No Clinical Signs, Symptoms or Conditions 10 10
Hematoma 9 9
Cyst(s) 9 9
Collapse 9 9
Wound Dehiscence 8 8
Adhesion(s) 8 8
Device Embedded In Tissue or Plaque 8 8
Osteolysis 7 7
Pulmonary Embolism 6 6
Aspiration/Inhalation 6 6
Impaired Healing 6 6
Foreign Body In Patient 6 6
Joint Disorder 4 4
Injury 4 4
Local Reaction 4 4
Scar Tissue 4 4
High Blood Pressure/ Hypertension 4 4
Muscle Weakness 4 4
Fever 3 3
Numbness 3 3
Overwear Syndrome 3 3
Skin Irritation 3 3
Tissue Damage 3 3
Seroma 3 3
Ossification 3 3
Bruise/Contusion 3 3
Cellulitis 2 2
Abdominal Pain 2 2
Nerve Damage 2 2
Muscular Rigidity 2 2
Debris, Bone Shedding 2 2
Tingling 2 2
Dizziness 2 2
Tissue Breakdown 2 2
Post Operative Wound Infection 2 2
Blood Loss 2 2
Excessive Tear Production 2 2
Neuropathy 2 2
Paresis 1 1
Hypersensitivity/Allergic reaction 1 1
Erosion 1 1
Calcium Deposits/Calcification 1 1
Deformity/ Disfigurement 1 1
Fluid Discharge 1 1
Sprain 1 1
Rash 1 1
Sepsis 1 1
Discharge 1 1
Visual Disturbances 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Thromboembolism 1 1
Disc Impingement 1 1
Weakness 1 1
Burning Sensation 1 1
Scarring 1 1
Seizures 1 1
Purulent Discharge 1 1
Hemorrhage/Bleeding 1 1
Chest Pain 1 1
Angina 1 1
Atrial Fibrillation 1 1
Bacterial Infection 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Biomet U.K., Ltd. II Feb-22-2017
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