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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, ankle, uncemented, non-constrained
Definition An ankle joint metal/polymer non-constrained uncemented prosthesis is a device intended to be implanted to replace an ankle joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a tibial component made of alloys, such as cobalt-chromium-molybdenum, and a talar component made of ultra-high molecular weight polyethylene.
Product CodeNTG
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
1 2 0 0 2 2 0 2 0 1 3 2 7 4 2 1

MDR Year MDR Reports MDR Events
2014 92 92
2015 341 341
2016 86 86
2017 82 82
2018 93 93
2019 129 129
2020 545 545
2021 89 89
2022 50 50
2023 12 12
2024 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 722 722
Fracture 137 137
Insufficient Information 123 123
Break 107 107
Appropriate Term/Code Not Available 85 85
Loss of Osseointegration 74 74
Naturally Worn 56 56
Unstable 52 52
Malposition of Device 40 40
Inadequacy of Device Shape and/or Size 28 28
Device Operates Differently Than Expected 26 26
Device Dislodged or Dislocated 25 25
Patient-Device Incompatibility 17 17
Device Slipped 16 16
Loose or Intermittent Connection 14 14
Unintended Movement 14 14
Migration 12 12
Improper or Incorrect Procedure or Method 12 12
Migration or Expulsion of Device 9 9
Material Deformation 8 8
Failure to Align 7 7
Degraded 5 5
Collapse 5 5
Therapeutic or Diagnostic Output Failure 5 5
Material Integrity Problem 4 4
Loss of or Failure to Bond 4 4
Entrapment of Device 4 4
Use of Device Problem 4 4
Failure to Osseointegrate 4 4
Off-Label Use 3 3
Failure To Adhere Or Bond 3 3
Material Twisted/Bent 3 3
Osseointegration Problem 3 3
Noise, Audible 3 3
Loosening of Implant Not Related to Bone-Ingrowth 3 3
Positioning Problem 2 2
Detachment of Device or Device Component 2 2
Detachment Of Device Component 2 2
Material Erosion 2 2
Device Expiration Issue 1 1
Flaked 1 1
Mechanical Problem 1 1
Material Fragmentation 1 1
Component Falling 1 1
Crack 1 1
Bent 1 1
Device Reprocessing Problem 1 1
Product Quality Problem 1 1
Difficult to Remove 1 1
Material Too Rigid or Stiff 1 1
Loss of Power 1 1
Stretched 1 1
Component Missing 1 1
Expiration Date Error 1 1
Device Tipped Over 1 1
Difficult to Advance 1 1
Deformation Due to Compressive Stress 1 1
Connection Problem 1 1
Extrusion 1 1
Device Contamination with Chemical or Other Material 1 1
Human-Device Interface Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Injury 454 454
Pain 266 266
Failure of Implant 212 212
No Code Available 148 148
Unspecified Infection 115 115
Cyst(s) 110 110
No Known Impact Or Consequence To Patient 85 85
Bone Fracture(s) 66 66
Implant Pain 51 51
Arthritis 47 47
Osteolysis 46 46
No Information 45 45
Insufficient Information 35 35
Post Operative Wound Infection 33 33
Impaired Healing 29 29
Swelling 29 29
Loss of Range of Motion 21 21
Bacterial Infection 20 20
Ossification 20 20
Death 19 19
Wound Dehiscence 19 19
Deformity/ Disfigurement 19 19
Ambulation Difficulties 17 17
Inadequate Osseointegration 15 15
Necrosis 13 13
Inflammation 13 13
Joint Laxity 12 12
Non-union Bone Fracture 11 11
Erythema 10 10
Capsular Contracture 9 9
Tissue Damage 9 9
Limited Mobility Of The Implanted Joint 9 9
Fall 8 8
Discomfort 7 7
Swelling/ Edema 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
No Clinical Signs, Symptoms or Conditions 6 6
Numbness 6 6
Arthralgia 6 6
Nerve Damage 5 5
Scar Tissue 4 4
Irritation 4 4
Reaction 4 4
Test Result 3 3
Joint Swelling 3 3
Joint Disorder 3 3
Joint Dislocation 3 3
Inadequate Pain Relief 3 3
Hypersensitivity/Allergic reaction 3 3
Pulmonary Embolism 3 3
Thrombosis 3 3
Tingling 2 2
Complaint, Ill-Defined 2 2
No Consequences Or Impact To Patient 2 2
Scarring 2 2
Synovitis 2 2
Edema 2 2
Damage to Ligament(s) 2 2
Fibrosis 2 2
Neuralgia 1 1
Limb Fracture 1 1
Multiple Fractures 1 1
Ankylosis 1 1
Depression 1 1
Tissue Breakdown 1 1
Foreign Body In Patient 1 1
Patient Problem/Medical Problem 1 1
Disc Impingement 1 1
Muscle Weakness 1 1
Cellulitis 1 1
Congenital Defect/Deformity 1 1
Sepsis 1 1
Staphylococcus Aureus 1 1
Anxiety 1 1
Cramp(s) 1 1

Recalls
Manufacturer Recall Class Date Posted
1 DT MedTech, LLC II Nov-07-2018
2 Exactech, Inc. II Jan-18-2024
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