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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
2018 141 141
2019 91 91
2020 65 65
2021 51 51
2022 32 32
2023 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Break 102 102
Insufficient Information 69 69
Adverse Event Without Identified Device or Use Problem 51 51
Fracture 46 46
Loss of Osseointegration 25 25
Appropriate Term/Code Not Available 13 13
Crack 12 12
Device Difficult to Setup or Prepare 12 12
Difficult to Insert 11 11
Osseointegration Problem 11 11
Packaging Problem 10 10
Material Deformation 10 10
Naturally Worn 10 10
Degraded 8 8
Migration 6 6
Unstable 5 5
Fitting Problem 4 4
Malposition of Device 4 4
Loss of or Failure to Bond 4 4
Positioning Problem 4 4
Scratched Material 4 4
Corroded 3 3
Device Operates Differently Than Expected 3 3
Device Dislodged or Dislocated 3 3
Inadequacy of Device Shape and/or Size 3 3
Dent in Material 2 2
Use of Device Problem 2 2
Failure to Osseointegrate 2 2
Decoupling 2 2
Noise, Audible 2 2
Loosening of Implant Not Related to Bone-Ingrowth 2 2
Material Integrity Problem 2 2
Material Twisted/Bent 1 1
Inaccurate Information 1 1
Off-Label Use 1 1
Material Too Rigid or Stiff 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
Bent 1 1
Positioning Failure 1 1
Material Disintegration 1 1
Material Erosion 1 1
Component Missing 1 1
Failure to Align 1 1
Installation-Related Problem 1 1
Device Damaged by Another Device 1 1
Deformation Due to Compressive Stress 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
No Consequences Or Impact To Patient 121 121
Pain 76 76
Injury 73 73
Unspecified Infection 39 39
Inadequate Osseointegration 31 31
No Known Impact Or Consequence To Patient 29 29
No Patient Involvement 23 23
Insufficient Information 21 21
No Clinical Signs, Symptoms or Conditions 18 18
Ambulation Difficulties 12 12
Bone Fracture(s) 9 9
No Code Available 8 8
Fall 7 7
Joint Laxity 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Joint Dislocation 4 4
No Information 3 3
Fluid Discharge 3 3
Patient Problem/Medical Problem 3 3
Failure of Implant 3 3
Arthritis 2 2
Loss of Range of Motion 2 2
Joint Disorder 2 2
Discomfort 2 2
Post Operative Wound Infection 2 2
Foreign Body In Patient 1 1
Subluxation 1 1
Swelling 1 1
Damage to Ligament(s) 1 1
Muscular Rigidity 1 1
Bacterial Infection 1 1
Cyst(s) 1 1
Erythema 1 1
Adhesion(s) 1 1

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