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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)
2020 2021 2022 2023 2024 2025
2 7 4 2 2 0

MDR Year MDR Reports MDR Events
2020 545 545
2021 89 89
2022 50 50
2023 12 12
2024 21 21
2025 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 521 521
Fracture 62 62
Loss of Osseointegration 45 45
Malposition of Device 29 29
Unstable 17 17
Naturally Worn 16 16
Inadequacy of Device Shape and/or Size 12 12
Device Dislodged or Dislocated 10 10
Migration 7 7
Break 6 6
Material Twisted/Bent 3 3
Insufficient Information 2 2
Material Integrity Problem 2 2
Loosening of Implant Not Related to Bone-Ingrowth 2 2
Appropriate Term/Code Not Available 2 2
Loss of or Failure to Bond 2 2
Noise, Audible 2 2
Crack 1 1
Unintended Movement 1 1
Therapeutic or Diagnostic Output Failure 1 1
Degraded 1 1
Material Fragmentation 1 1
Use of Device Problem 1 1
Material Deformation 1 1
Product Quality Problem 1 1
Detachment of Device or Device Component 1 1
Loose or Intermittent Connection 1 1
Deformation Due to Compressive Stress 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Injury 359 359
Failure of Implant 144 144
Implant Pain 51 51
Pain 50 50
Insufficient Information 38 38
Bone Fracture(s) 34 34
Cyst(s) 33 33
Unspecified Infection 31 31
Osteolysis 31 31
Post Operative Wound Infection 30 30
Impaired Healing 23 23
Deformity/ Disfigurement 19 19
Bacterial Infection 18 18
Loss of Range of Motion 16 16
Wound Dehiscence 13 13
Joint Laxity 12 12
Ossification 12 12
Ambulation Difficulties 11 11
Capsular Contracture 9 9
No Code Available 9 9
Swelling 8 8
Erythema 8 8
No Known Impact Or Consequence To Patient 8 8
Death 7 7
Swelling/ Edema 7 7
No Clinical Signs, Symptoms or Conditions 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Nerve Damage 5 5
Arthritis 5 5
Inflammation 4 4
No Information 4 4
Non-union Bone Fracture 4 4
Numbness 3 3
Limited Mobility Of The Implanted Joint 3 3
Edema 2 2
Discomfort 2 2
Inadequate Osseointegration 2 2
Tissue Damage 2 2
Tingling 2 2
Inadequate Pain Relief 2 2
Fibrosis 2 2
Multiple Fractures 1 1
Rash 1 1
Synovitis 1 1
Muscle Weakness 1 1
Necrosis 1 1
Depression 1 1
Abscess 1 1
Limb Fracture 1 1
Ankylosis 1 1

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