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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 0

MDR Year MDR Reports MDR Events
2025 34 34
2026 15 15

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 27 27
Device Dislodged or Dislocated 14 14
Material Deformation 8 8
Migration 5 5
Mechanical Jam 4 4
Insufficient Information 3 3
Osseointegration Problem 3 3
Biocompatibility 3 3
Loosening of Implant Not Related to Bone-Ingrowth 2 2
Break 1 1
Microbial Contamination of Device 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Detachment of Device or Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Implant Pain 30 30
Metal Related Pathology 19 19
Ossification 5 5
Hypersensitivity/Allergic reaction 3 3
Inadequate Osseointegration 3 3
Bone Fracture(s) 2 2
Post Operative Wound Infection 2 2
Insufficient Information 2 2
Skin Infection 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Post Traumatic Wound Infection 1 1
Pyogenic Infection 1 1
Swelling/ Edema 1 1

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