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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, knee, patello/femorotibial, semi-constrained, uhmwpe, pegged, cemented, polymer/metal/polymer
Regulation Description Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
Product CodeMBV
Regulation Number 888.3560
Device Class 2

MDR Year MDR Reports MDR Events
2020 10 10
2021 1 1
2022 6 6
2023 7 7
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 10 10
Fracture 4 4
Loss of or Failure to Bond 3 3
Degraded 2 2
Detachment of Device or Device Component 2 2
Noise, Audible 2 2
Unstable 1 1
Malposition of Device 1 1
Material Erosion 1 1
Insufficient Information 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Naturally Worn 1 1
Osseointegration Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 6 6
Failure of Implant 4 4
Insufficient Information 4 4
Limited Mobility Of The Implanted Joint 3 3
Metal Related Pathology 3 3
No Information 3 3
Bone Fracture(s) 3 3
Swelling 3 3
Wound Dehiscence 2 2
No Clinical Signs, Symptoms or Conditions 2 2
Synovitis 2 2
Osteopenia/ Osteoporosis 2 2
Swelling/ Edema 2 2
Unspecified Infection 1 1
Sepsis 1 1
Inadequate Osseointegration 1 1
Adhesion(s) 1 1
Local Reaction 1 1
Ossification 1 1
Muscular Rigidity 1 1
Loss of Range of Motion 1 1
Discomfort 1 1
Fall 1 1
Reaction 1 1
Unspecified Tissue Injury 1 1

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