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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device prosthesis, total talus replacement, metal
Definition Replaces the native talus
Product CodeQNN
Device Class Humanitarian Device Exemption

MDR Year MDR Reports MDR Events
2023 3 3
2024 5 5
2025 6 6
2026 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 11 11
Patient-Device Incompatibility 4 4
Inadequacy of Device Shape and/or Size 3 3
Appropriate Device Problem Term/Code Not Available 2 2
Implant subsidence 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Arthritis 7 7
Limb Pain 5 5
Pain 3 3
Arthralgia 2 2
Unspecified Infection 1 1
Aseptic loosening 1 1
Wound Dehiscence 1 1
Hypersensitivity/Allergic reaction 1 1
Joint Dislocation 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Necrosis 1 1
Cyst(s) 1 1
Ischemia 1 1
Implant Pain 1 1
Myalgia 1 1
Osteopenia/ Osteoporosis 1 1
Medical device site infection 1 1
Skin Discoloration 1 1
Osteomyelitis 1 1
Ambulation or Postural Difficulties 1 1
Muscle/Tendon Damage 1 1
Swelling/ Edema 1 1
Joint Impingement 1 1

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