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TPLC - Total Product Life Cycle
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Device knee arthroplasty implantation system
Definition Intended to be used to assist in the implantation of a specific knee arthroplasty device or a set of specific knee arthroplasty devices. Indicated to include guiding alignment, making or establishing cuts, selecting, sizing, attaching, positioning or orienting implant components.
Product CodeOOG
Regulation Number 888.3560
Device Class 2


Premarket Reviews
ManufacturerDecision
CONFORMIS INC.
  SUBSTANTIALLY EQUIVALENT 1
ENHATCH, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 7 7
2015 30 30
2016 4 4
2017 10 10
2018 2 2
2019 15 15
2020 8 8
2021 4 4
2022 18 18
2023 23 23
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Loosening of Implant Not Related to Bone-Ingrowth 23 23
Break 20 20
Adverse Event Without Identified Device or Use Problem 15 15
Compatibility Problem 12 12
Insufficient Information 10 10
Patient-Device Incompatibility 8 8
Loose or Intermittent Connection 7 7
Patient Device Interaction Problem 5 5
Device-Device Incompatibility 5 5
Unstable 3 3
Component Missing 2 2
Incorrect Measurement 2 2
Nonstandard Device 2 2
Delivered as Unsterile Product 2 2
Device Operates Differently Than Expected 2 2
Material Deformation 2 2
Physical Property Issue 1 1
Scratched Material 1 1
Device Packaging Compromised 1 1
Device Dislodged or Dislocated 1 1
Failure To Adhere Or Bond 1 1
Appropriate Term/Code Not Available 1 1
Device Fell 1 1
Material Rupture 1 1
Material Separation 1 1
Device Slipped 1 1
Detachment Of Device Component 1 1
Crack 1 1
Entrapment of Device 1 1
Loss of Osseointegration 1 1
Defective Device 1 1
Malposition of Device 1 1
Application Network Problem 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 26 26
No Known Impact Or Consequence To Patient 22 22
Failure of Implant 20 20
No Clinical Signs, Symptoms or Conditions 18 18
Unspecified Infection 17 17
Limited Mobility Of The Implanted Joint 13 13
Patient Problem/Medical Problem 12 12
No Code Available 11 11
Insufficient Information 6 6
No Information 5 5
Joint Disorder 4 4
No Consequences Or Impact To Patient 3 3
Unspecified Tissue Injury 3 3
Inadequate Osseointegration 3 3
Sleep Dysfunction 2 2
Ambulation Difficulties 2 2
Implant Pain 2 2
Swelling/ Edema 2 2
Stenosis 2 2
Bone Fracture(s) 2 2
Hematoma 1 1
Hemorrhage/Bleeding 1 1
Reaction 1 1
Discomfort 1 1
Injury 1 1
Inflammation 1 1
Nerve Damage 1 1
Rash 1 1
Sepsis 1 1
Weakness 1 1
Cyst(s) 1 1
Fibrosis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 ConforMIS, Inc. II Oct-21-2015
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