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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, knee, patello/femorotibial, semi-constrained, uhmwpe, pegged, cemented, polymer/metal/polymer
Product CodeMBV
Regulation Number 888.3560
Device Class 2

MDR Year MDR Reports MDR Events
2018 5 5
2019 16 16
2020 10 10
2021 1 1
2022 6 6
2023 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 10 10
Loss of or Failure to Bond 6 6
Loosening of Implant Not Related to Bone-Ingrowth 6 6
Fracture 4 4
Insufficient Information 3 3
Packaging Problem 2 2
Noise, Audible 2 2
Detachment of Device or Device Component 2 2
Device Packaging Compromised 2 2
Degraded 2 2
Unstable 2 2
Incomplete or Missing Packaging 1 1
Tear, Rip or Hole in Device Packaging 1 1
Malposition of Device 1 1
Material Erosion 1 1
Misassembled 1 1
Delivered as Unsterile Product 1 1
Osseointegration Problem 1 1
Appropriate Term/Code Not Available 1 1
Migration 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 17 17
Limited Mobility Of The Implanted Joint 9 9
Swelling 5 5
Failure of Implant 4 4
No Information 4 4
No Patient Involvement 4 4
Insufficient Information 4 4
Metal Related Pathology 3 3
Bone Fracture(s) 3 3
Ambulation Difficulties 3 3
Swelling/ Edema 2 2
No Clinical Signs, Symptoms or Conditions 2 2
Osteopenia/ Osteoporosis 2 2
Erosion 2 2
Synovitis 2 2
No Consequences Or Impact To Patient 2 2
Discomfort 1 1
Reaction 1 1
Loss of Range of Motion 1 1
Local Reaction 1 1
Sepsis 1 1
Fall 1 1
Ossification 1 1
Adhesion(s) 1 1
Unspecified Infection 1 1
Muscle Weakness 1 1
Muscular Rigidity 1 1
Inadequate Osseointegration 1 1
No Code Available 1 1
No Known Impact Or Consequence To Patient 1 1

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