Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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


Premarket Reviews
ManufacturerDecision
CONFORMIS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MAKO SURGICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
MAKO SURGICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 75 75
2015 55 55
2016 93 93
2017 150 150
2018 141 141
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
Insufficient Information 218 218
Break 195 195
Adverse Event Without Identified Device or Use Problem 112 112
Fracture 102 102
Loss of Osseointegration 47 47
Crack 27 27
Material Integrity Problem 26 26
Appropriate Term/Code Not Available 25 25
Material Deformation 24 24
Naturally Worn 20 20
Difficult to Insert 20 20
Osseointegration Problem 15 15
Device Operates Differently Than Expected 15 15
Packaging Problem 14 14
Device Difficult to Setup or Prepare 13 13
Degraded 13 13
Positioning Problem 13 13
Material Discolored 12 12
Malposition of Device 12 12
Fitting Problem 11 11
Device Dislodged or Dislocated 11 11
Mechanical Problem 11 11
Device Slipped 11 11
Scratched Material 11 11
Unstable 10 10
Loose or Intermittent Connection 9 9
Migration 9 9
Loss of or Failure to Bond 7 7
Detachment Of Device Component 7 7
Noise, Audible 6 6
Unintended Movement 5 5
Device Damaged by Another Device 5 5
Use of Device Problem 4 4
Device Packaging Compromised 3 3
Device Contamination with Chemical or Other Material 3 3
Device Contaminated During Manufacture or Shipping 3 3
Failure To Adhere Or Bond 3 3
Corroded 3 3
Material Fragmentation 3 3
Inadequacy of Device Shape and/or Size 3 3
Off-Label Use 3 3
Migration or Expulsion of Device 2 2
Difficult to Remove 2 2
Sticking 2 2
Unexpected Therapeutic Results 2 2
Decoupling 2 2
Bent 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Dent in Material 2 2
Detachment of Device or Device Component 2 2
Failure to Osseointegrate 2 2
No Apparent Adverse Event 2 2
Loosening of Implant Not Related to Bone-Ingrowth 2 2
Inaccurate Information 1 1
Improper or Incorrect Procedure or Method 1 1
Component Missing 1 1
Tear, Rip or Hole in Device Packaging 1 1
Failure to Align 1 1
Difficult to Open or Remove Packaging Material 1 1
Patient-Device Incompatibility 1 1
Biocompatibility 1 1
Deformation Due to Compressive Stress 1 1
Contamination /Decontamination Problem 1 1
Connection Problem 1 1
Material Twisted/Bent 1 1
Mechanical Jam 1 1
Physical Property Issue 1 1
Split 1 1
Installation-Related Problem 1 1
Material Distortion 1 1
Component Falling 1 1
Hole In Material 1 1
Positioning Failure 1 1
Material Disintegration 1 1
Material Erosion 1 1
Device Expiration Issue 1 1
Device Inoperable 1 1
Material Too Rigid or Stiff 1 1
Moisture Damage 1 1
Difficult To Position 1 1
Product Quality Problem 1 1
Labelling, Instructions for Use or Training Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 222 222
Pain 181 181
Injury 157 157
No Known Impact Or Consequence To Patient 114 114
Unspecified Infection 77 77
No Code Available 55 55
Inadequate Osseointegration 51 51
Insufficient Information 38 38
No Clinical Signs, Symptoms or Conditions 31 31
No Patient Involvement 27 27
Bone Fracture(s) 24 24
No Information 19 19
Ambulation Difficulties 17 17
Fall 12 12
Arthritis 11 11
Discomfort 11 11
Swelling 8 8
Joint Laxity 8 8
Failure of Implant 6 6
Loss of Range of Motion 5 5
Joint Disorder 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Foreign Body In Patient 4 4
Joint Dislocation 4 4
Post Operative Wound Infection 4 4
Reaction 4 4
Arthralgia 3 3
Patient Problem/Medical Problem 3 3
Fluid Discharge 3 3
Device Embedded In Tissue or Plaque 3 3
Limited Mobility Of The Implanted Joint 2 2
Subluxation 2 2
Inflammation 2 2
Damage to Ligament(s) 2 2
Cyst(s) 2 2
Hypersensitivity/Allergic reaction 2 2
Adhesion(s) 1 1
Erythema 1 1
Rheumatoid Arthritis 1 1
Bacterial Infection 1 1
Muscular Rigidity 1 1
Joint Swelling 1 1
Fungal Infection 1 1
Osteopenia/ Osteoporosis 1 1
Osteolysis 1 1
Impaired Healing 1 1
Complaint, Ill-Defined 1 1
Therapeutic Response, Decreased 1 1

Recalls
Manufacturer Recall Class Date Posted
1 ConforMIS, Inc. II Oct-21-2015
2 Mako Surgical Corporation II Jun-01-2018
3 Mako Surgical Corporation II Mar-01-2016
4 Mako Surgical Corporation II Mar-04-2014
5 Stryker Howmedica Osteonics Corp. II Jan-11-2012
-
-