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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, knee patellofemorotibial, partial, semi-constrained, cemented, polymer/metal/polymer
Definition The device is intended to replace the medial condyle and the patellofemoral compartment of the distal femur with a single device. The device is meant to be used with a uni-compartmental tibial base and insert and a resurfacing patella. The device is intended to be used with bone cement.
Product CodeNPJ
Regulation Number 888.3560
Device Class 2

MDR Year MDR Reports MDR Events
2019 91 91
2020 65 65
2021 51 51
2022 32 32
2023 52 52
2024 19 19

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 70 70
Insufficient Information 56 56
Break 40 40
Loss of Osseointegration 27 27
Fracture 24 24
Difficult to Insert 14 14
Appropriate Term/Code Not Available 12 12
Material Discolored 11 11
Osseointegration Problem 9 9
Device Difficult to Setup or Prepare 9 9
Migration 9 9
Naturally Worn 7 7
Degraded 7 7
Loss of or Failure to Bond 6 6
Device Dislodged or Dislocated 6 6
Unstable 5 5
Crack 3 3
Inadequacy of Device Shape and/or Size 3 3
Positioning Problem 3 3
Unintended Movement 3 3
Material Integrity Problem 2 2
Corroded 2 2
Use of Device Problem 2 2
Failure to Osseointegrate 2 2
Fitting Problem 2 2
Loosening of Implant Not Related to Bone-Ingrowth 2 2
Inaccurate Information 1 1
Component Missing 1 1
Labelling, Instructions for Use or Training Problem 1 1
Loose or Intermittent Connection 1 1
Mechanical Problem 1 1
Moisture Damage 1 1
Positioning Failure 1 1
Material Disintegration 1 1
Material Erosion 1 1
Packaging Problem 1 1
Noise, Audible 1 1
Material Deformation 1 1
Off-Label Use 1 1
Failure to Align 1 1
Malposition of Device 1 1
Biocompatibility 1 1
Contamination /Decontamination Problem 1 1
Detachment of Device or Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 82 82
Injury 52 52
No Consequences Or Impact To Patient 47 47
Unspecified Infection 42 42
Insufficient Information 38 38
Inadequate Osseointegration 32 32
No Clinical Signs, Symptoms or Conditions 30 30
No Known Impact Or Consequence To Patient 15 15
Ambulation Difficulties 12 12
Fall 10 10
Bone Fracture(s) 8 8
Joint Laxity 8 8
No Code Available 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
No Patient Involvement 3 3
Fluid Discharge 3 3
Arthritis 3 3
Loss of Range of Motion 3 3
Joint Dislocation 3 3
Post Operative Wound Infection 2 2
Joint Disorder 2 2
Discomfort 2 2
Failure of Implant 2 2
Subluxation 2 2
No Information 1 1
Adhesion(s) 1 1
Damage to Ligament(s) 1 1
Muscular Rigidity 1 1
Bacterial Infection 1 1
Cyst(s) 1 1
Hypersensitivity/Allergic reaction 1 1
Swelling 1 1

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