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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)
2019 2020 2021 2022 2023 2024
3 2 7 4 2 1

MDR Year MDR Reports MDR Events
2019 129 129
2020 545 545
2021 89 89
2022 50 50
2023 12 12
2024 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 544 544
Fracture 77 77
Loss of Osseointegration 74 74
Naturally Worn 35 35
Break 33 33
Unstable 31 31
Malposition of Device 29 29
Device Dislodged or Dislocated 12 12
Appropriate Term/Code Not Available 12 12
Inadequacy of Device Shape and/or Size 11 11
Migration 10 10
Noise, Audible 3 3
Material Twisted/Bent 3 3
Therapeutic or Diagnostic Output Failure 3 3
Loose or Intermittent Connection 3 3
Device Slipped 2 2
Material Deformation 2 2
Material Integrity Problem 2 2
Loss of or Failure to Bond 2 2
Detachment of Device or Device Component 2 2
Loosening of Implant Not Related to Bone-Ingrowth 2 2
Insufficient Information 2 2
Unintended Movement 1 1
Deformation Due to Compressive Stress 1 1
Use of Device Problem 1 1
Product Quality Problem 1 1
Difficult to Remove 1 1
Crack 1 1
Degraded 1 1
Material Fragmentation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Injury 450 450
Failure of Implant 153 153
Pain 75 75
Implant Pain 49 49
Unspecified Infection 37 37
Cyst(s) 37 37
Insufficient Information 35 35
Bone Fracture(s) 34 34
Osteolysis 33 33
Post Operative Wound Infection 31 31
Impaired Healing 23 23
Deformity/ Disfigurement 19 19
No Known Impact Or Consequence To Patient 18 18
Bacterial Infection 18 18
Loss of Range of Motion 15 15
No Code Available 15 15
Ambulation Difficulties 14 14
Wound Dehiscence 13 13
Ossification 12 12
Joint Laxity 12 12
Swelling 11 11
Capsular Contracture 9 9
Erythema 8 8
No Information 8 8
Death 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
Arthritis 5 5
Nerve Damage 5 5
Non-union Bone Fracture 4 4
Inflammation 4 4
Numbness 3 3
Limited Mobility Of The Implanted Joint 3 3
Discomfort 3 3
Inadequate Pain Relief 2 2
Fibrosis 2 2
Inadequate Osseointegration 2 2
Synovitis 2 2
Tissue Damage 2 2
Tingling 2 2
Edema 2 2
Anxiety 1 1
Damage to Ligament(s) 1 1
Muscle Weakness 1 1
Necrosis 1 1
Depression 1 1
Arthralgia 1 1
Ankylosis 1 1
Neuralgia 1 1
Limb Fracture 1 1
Multiple Fractures 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Exactech, Inc. II Jan-18-2024
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