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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)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
0 3 6 5 8 2 4 6 8 14 12 2 1 3 1 0

MDR Year MDR Reports MDR Events
2014 228 228
2015 590 590
2016 531 531
2017 676 676
2018 251 251
2019 518 518
2020 190 190
2021 234 234
2022 281 281
2023 276 276
2024 48 48

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 1298 1298
Adverse Event Without Identified Device or Use Problem 669 669
Device Dislodged or Dislocated 429 429
Appropriate Term/Code Not Available 259 259
Loose or Intermittent Connection 212 212
Migration or Expulsion of Device 211 211
Fracture 196 196
Patient Device Interaction Problem 151 151
Unstable 117 117
Loosening of Implant Not Related to Bone-Ingrowth 98 98
Device Slipped 97 97
Break 62 62
Mechanical Problem 59 59
Material Integrity Problem 53 53
Naturally Worn 43 43
Malposition of Device 43 43
Noise, Audible 36 36
Unintended Movement 35 35
Loss of or Failure to Bond 29 29
Device Operates Differently Than Expected 28 28
Migration 25 25
Packaging Problem 17 17
Material Erosion 16 16
Inadequacy of Device Shape and/or Size 16 16
Use of Device Problem 14 14
Degraded 14 14
Manufacturing, Packaging or Shipping Problem 13 13
Detachment Of Device Component 12 12
Tear, Rip or Hole in Device Packaging 9 9
Metal Shedding Debris 8 8
Off-Label Use 8 8
Positioning Problem 8 8
Device Markings/Labelling Problem 7 7
Collapse 7 7
Improper or Incorrect Procedure or Method 7 7
Scratched Material 6 6
Detachment of Device or Device Component 5 5
Unsealed Device Packaging 5 5
Delivered as Unsterile Product 5 5
Material Separation 4 4
Material Fragmentation 4 4
Device Packaging Compromised 4 4
Fitting Problem 4 4
Material Deformation 3 3
Device-Device Incompatibility 3 3
No Device Output 3 3
Difficult to Open or Remove Packaging Material 3 3
Component Falling 3 3
Entrapment of Device 3 3
Material Rupture 3 3
Disassembly 3 3
Missing Information 3 3
Failure To Adhere Or Bond 3 3
Failure to Osseointegrate 3 3
Material Twisted/Bent 3 3
Patient-Device Incompatibility 3 3
Pitted 2 2
Problem with Sterilization 2 2
Device Appears to Trigger Rejection 2 2
Unexpected Therapeutic Results 2 2
Overcorrection 2 2
Biocompatibility 2 2
Torn Material 2 2
Inaccurate Delivery 2 2
Failure to Align 2 2
Incorrect Device Or Component Shipped 2 2
Device Contamination with Chemical or Other Material 2 2
Mechanical Jam 2 2
Component Incompatible 2 2
Material Too Rigid or Stiff 2 2
Misassembly by Users 1 1
Device Handling Problem 1 1
Material Protrusion/Extrusion 1 1
Device Contaminated During Manufacture or Shipping 1 1
Sticking 1 1
Split 1 1
Labelling, Instructions for Use or Training Problem 1 1
Output Problem 1 1
Dull, Blunt 1 1
Component Missing 1 1
No Apparent Adverse Event 1 1
Structural Problem 1 1
Deformation Due to Compressive Stress 1 1
Shipping Damage or Problem 1 1
Inadequate Instructions for Healthcare Professional 1 1
Connection Problem 1 1
Increase in Pressure 1 1
Device Inoperable 1 1
Contamination 1 1
Product Quality Problem 1 1
Difficult to Remove 1 1
Human-Device Interface Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 1110 1110
No Information 840 840
No Code Available 568 568
Joint Dislocation 316 316
Insufficient Information 244 244
Unspecified Infection 212 212
Failure of Implant 191 191
Bone Fracture(s) 154 154
Swelling 111 111
No Known Impact Or Consequence To Patient 105 105
Ambulation Difficulties 102 102
Death 80 80
Loss of Range of Motion 75 75
No Clinical Signs, Symptoms or Conditions 72 72
Arthritis 65 65
Swelling/ Edema 60 60
Fall 45 45
No Consequences Or Impact To Patient 45 45
Synovitis 34 34
Limited Mobility Of The Implanted Joint 33 33
Damage to Ligament(s) 32 32
Osteolysis 23 23
Inflammation 22 22
Patient Problem/Medical Problem 21 21
Reaction 20 20
Edema 20 20
Hematoma 19 19
Wound Dehiscence 18 18
Cyst(s) 17 17
Necrosis 17 17
No Patient Involvement 17 17
Discomfort 16 16
Foreign Body In Patient 15 15
Scar Tissue 14 14
Hypersensitivity/Allergic reaction 13 13
Pulmonary Embolism 13 13
Sleep Dysfunction 13 13
Joint Swelling 13 13
Collapse 11 11
Metal Related Pathology 11 11
Hemorrhage/Bleeding 11 11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 10 10
Cramp(s) /Muscle Spasm(s) 10 10
Joint Laxity 9 9
Osteopenia/ Osteoporosis 9 9
Adhesion(s) 9 9
Tissue Damage 8 8
Tissue Breakdown 8 8
Device Embedded In Tissue or Plaque 8 8
Numbness 7 7
Burning Sensation 7 7
Injury 7 7
Aspiration/Inhalation 6 6
Inadequate Osseointegration 6 6
Deformity/ Disfigurement 6 6
Impaired Healing 6 6
Joint Disorder 5 5
Fibrosis 5 5
Cellulitis 5 5
Muscle Weakness 5 5
Complaint, Ill-Defined 5 5
Loss of Vision 4 4
Rash 4 4
Local Reaction 4 4
High Blood Pressure/ Hypertension 4 4
Fatigue 4 4
Fever 4 4
Test Result 4 4
Skin Inflammation/ Irritation 4 4
Implant Pain 4 4
Muscle/Tendon Damage 3 3
Hyperextension 3 3
Fluid Discharge 3 3
Fungal Infection 3 3
Bacterial Infection 3 3
Erosion 3 3
Bruise/Contusion 3 3
Ossification 3 3
Sepsis 3 3
Seroma 3 3
Skin Irritation 3 3
Toxicity 3 3
Rupture 3 3
Overwear Syndrome 3 3
Excessive Tear Production 2 2
Discharge 2 2
Tingling 2 2
Dizziness 2 2
Scarring 2 2
Pneumonia 2 2
Staphylococcus Aureus 2 2
Nerve Damage 2 2
Neuropathy 2 2
Abdominal Pain 2 2
Angina 2 2
Debris, Bone Shedding 2 2
Foreign Body Reaction 2 2
Muscular Rigidity 2 2
Post Operative Wound Infection 2 2
Blood Loss 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Biomet U.K., Ltd. II Feb-22-2017
2 Biomet U.K., Ltd. II Apr-15-2013
3 Biomet, Inc. II Feb-03-2009
4 Endotec, Inc. II Jan-11-2012
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