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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
2017 150 150
2018 141 141
2019 91 91
2020 64 64
2021 51 51
2022 26 26

Device Problems MDRs with this Device Problem Events in those MDRs
Break 150 150
Insufficient Information 119 119
Fracture 67 67
Adverse Event Without Identified Device or Use Problem 61 61
Loss of Osseointegration 36 36
Crack 20 20
Material Deformation 18 18
Appropriate Term/Code Not Available 14 14
Device Difficult to Setup or Prepare 13 13
Difficult to Insert 12 12
Naturally Worn 12 12
Packaging Problem 12 12
Scratched Material 11 11
Osseointegration Problem 11 11
Fitting Problem 9 9
Malposition of Device 9 9
Mechanical Problem 8 8
Degraded 8 8
Material Integrity Problem 8 8
Device Operates Differently Than Expected 8 8
Positioning Problem 8 8
Migration 5 5
Unstable 5 5
Loose or Intermittent Connection 4 4
Noise, Audible 4 4
Device Damaged by Another Device 3 3
Device Dislodged or Dislocated 3 3
Corroded 3 3
Loss of or Failure to Bond 3 3
Decoupling 2 2
Material Fragmentation 2 2
Use of Device Problem 2 2
Failure to Osseointegrate 2 2
Inadequacy of Device Shape and/or Size 2 2
Dent in Material 2 2
Unintended Movement 2 2
Loosening of Implant Not Related to Bone-Ingrowth 2 2
Inaccurate Information 1 1
Physical Property Issue 1 1
Installation-Related Problem 1 1
Material Twisted/Bent 1 1
Mechanical Jam 1 1
Material Distortion 1 1
Device Slipped 1 1
Sticking 1 1
Migration or Expulsion of Device 1 1
Moisture Damage 1 1
Off-Label Use 1 1
Material Too Rigid or Stiff 1 1
Deformation Due to Compressive Stress 1 1
Contamination /Decontamination Problem 1 1
Detachment of Device or Device Component 1 1
Component Missing 1 1
Failure to Align 1 1
Labelling, Instructions for Use or Training Problem 1 1
Bent 1 1
Detachment Of Device Component 1 1
Positioning Failure 1 1
Material Discolored 1 1
Material Disintegration 1 1
Material Erosion 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 176 176
Injury 122 122
Pain 106 106
No Known Impact Or Consequence To Patient 66 66
Unspecified Infection 47 47
Inadequate Osseointegration 41 41
No Patient Involvement 25 25
Insufficient Information 17 17
No Clinical Signs, Symptoms or Conditions 16 16
Ambulation Difficulties 12 12
Bone Fracture(s) 11 11
Discomfort 10 10
No Code Available 10 10
No Information 9 9
Arthritis 8 8
Fall 7 7
Swelling 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Joint Laxity 4 4
Failure of Implant 4 4
Joint Disorder 4 4
Joint Dislocation 4 4
Loss of Range of Motion 3 3
Fluid Discharge 3 3
Foreign Body In Patient 3 3
Patient Problem/Medical Problem 3 3
Device Embedded In Tissue or Plaque 2 2
Reaction 2 2
Post Operative Wound Infection 2 2
Inflammation 2 2
Damage to Ligament(s) 1 1
Impaired Healing 1 1
Adhesion(s) 1 1
Rheumatoid Arthritis 1 1
Bacterial Infection 1 1
Cyst(s) 1 1
Erythema 1 1
Limited Mobility Of The Implanted Joint 1 1
Subluxation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Mako Surgical Corporation II Jun-01-2018
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