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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
Regulation Description Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
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 49 49

Device Problems MDRs with this Device Problem Events in those MDRs
Break 150 150
Insufficient Information 117 117
Fracture 64 64
Adverse Event Without Identified Device or Use Problem 43 43
Loss of Osseointegration 32 32
Crack 20 20
Material Deformation 18 18
Appropriate Term/Code Not Available 13 13
Device Difficult to Setup or Prepare 13 13
Packaging Problem 12 12
Scratched Material 11 11
Naturally Worn 11 11
Difficult to Insert 11 11
Osseointegration Problem 10 10
Fitting Problem 9 9
Malposition of Device 9 9
Mechanical Problem 8 8
Material Integrity Problem 8 8
Device Operates Differently Than Expected 8 8
Positioning Problem 8 8
Degraded 7 7
Unstable 5 5
Migration 5 5
Noise, Audible 4 4
Loose or Intermittent Connection 4 4
Corroded 3 3
Device Damaged by Another Device 3 3
Device Dislodged or Dislocated 3 3
Dent in Material 2 2
Unintended Movement 2 2
Loosening of Implant Not Related to Bone-Ingrowth 2 2
Decoupling 2 2
Material Fragmentation 2 2
Loss of or Failure to Bond 2 2
Use of Device Problem 2 2
Failure to Osseointegrate 2 2
Inadequacy of Device Shape and/or Size 2 2
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
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
Labelling, Instructions for Use or Training Problem 1 1
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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 176 176
Injury 122 122
Pain 94 94
No Known Impact Or Consequence To Patient 66 66
Inadequate Osseointegration 35 35
Unspecified Infection 32 32
No Patient Involvement 25 25
No Clinical Signs, Symptoms or Conditions 15 15
Insufficient Information 14 14
Bone Fracture(s) 11 11
No Code Available 10 10
No Information 9 9
Discomfort 9 9
Ambulation Difficulties 8 8
Arthritis 8 8
Swelling 7 7
Failure of Implant 4 4
Joint Disorder 4 4
Joint Dislocation 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Joint Laxity 4 4
Fall 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
Loss of Range of Motion 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
Fluid Discharge 1 1
Subluxation 1 1

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