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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, wrist, 2 part metal-plastic articulation, semi-constrained
Regulation Description Wrist joint metal/polymer semi-constrained cemented prosthesis.
Product CodeJWI
Regulation Number 888.3800
Device Class 2

MDR Year MDR Reports MDR Events
2022 1 1
2023 2 2
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Naturally Worn 4 4
Unstable 2 2
Material Discolored 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Fracture 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 4 4
Swelling/ Edema 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Loss of Range of Motion 2 2
Discomfort 2 2
Joint Laxity 2 2
Unspecified Infection 1 1
Hypersensitivity/Allergic reaction 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Synovitis 1 1
Foreign Body Reaction 1 1
Bone Shedding Debris 1 1
Osteolysis 1 1
Insufficient Information 1 1
Scar Tissue 1 1

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