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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, finger, semi-constrained, metal/polymer
Definition A Prosthesis, finger, semi-constrained, metal/polymer, is intended to replace the total first carpometacarpal joint to reduce pain and improve function when the native joint is compromised due to disease such as osteoarthritis.
Product CodeSFA
Device Class 3

Premarket Approvals (PMA)
2021 2022 2023 2024 2025 2026
0 0 0 0 4 3

MDR Year MDR Reports MDR Events
2025 34 34
2026 82 82

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 35 35
Device Dislodged or Dislocated 34 34
Break 18 18
Material Deformation 16 16
Migration 13 13
Mechanical Jam 13 13
Loosening of Implant Not Related to Bone-Ingrowth 12 12
Adverse Event Without Identified Device or Use Problem 6 6
Osseointegration Problem 6 6
Naturally Worn 5 5
Insufficient Device Problem Information 3 3
Biocompatibility 3 3
Malposition of Device 2 2
Microbial Contamination of Device 2 2
Material Separation 2 2
Deformation Due to Compressive Stress 2 2
Noise, Audible 2 2
Peeled/Delaminated 1 1
Defective Device 1 1
Contamination 1 1
Misassembled During Installation 1 1
Implant subsidence 1 1
Detachment of Device or Device Component 1 1
Loss of Osseointegration 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Implant Pain 61 61
Metal Related Pathology 37 37
Joint Impingement 34 34
Extraskeletal ossification 12 12
Aseptic loosening 11 11
Joint Dislocation 6 6
Inadequate Osseointegration 6 6
Bone Fracture(s) 6 6
Loss of Range of Motion 5 5
Insufficient Information 4 4
Hypersensitivity/Allergic reaction 3 3
No Clinical Signs, Symptoms or Conditions 3 3
Skin Infection 2 2
Failure of Implant 2 2
Synovitis 2 2
Post Operative Wound Infection 2 2
Wound Infection 2 2
Osteolysis 2 2
Swelling/ Edema 2 2
Cyst(s) 1 1
Medical device site infection 1 1
Graft failure 1 1
Pyogenic Infection 1 1
Periprosthetic fracture 1 1

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