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U.S. Department of Health and Human Services

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
2019 15 15
2020 8 8
2021 4 4
2022 18 18
2023 23 23
2024 64 64

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 46 46
Loosening of Implant Not Related to Bone-Ingrowth 24 24
Compatibility Problem 12 12
Break 11 11
Patient Device Interaction Problem 11 11
Device Appears to Trigger Rejection 8 8
Adverse Event Without Identified Device or Use Problem 6 6
Device-Device Incompatibility 4 4
Fracture 4 4
Incorrect Measurement 3 3
Crack 1 1
Device Fell 1 1
Defective Device 1 1
Scratched Material 1 1
Material Deformation 1 1
Material Separation 1 1
Detachment of Device or Device Component 1 1
Application Network Problem 1 1
Loss of Osseointegration 1 1
Biocompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Failure of Implant 71 71
No Clinical Signs, Symptoms or Conditions 21 21
Pain 18 18
Unspecified Infection 13 13
Limited Mobility Of The Implanted Joint 13 13
Patient Problem/Medical Problem 12 12
Insufficient Information 8 8
Foreign Body Reaction 4 4
Joint Disorder 3 3
Inadequate Osseointegration 3 3
Unspecified Tissue Injury 3 3
Sleep Dysfunction 2 2
Implant Pain 2 2
No Known Impact Or Consequence To Patient 2 2
Stenosis 2 2
Swelling/ Edema 2 2
No Consequences Or Impact To Patient 2 2
Hypersensitivity/Allergic reaction 1 1
Sepsis 1 1
Cyst(s) 1 1
Bone Fracture(s) 1 1
Hematoma 1 1
Inflammation 1 1
Hemorrhage/Bleeding 1 1
Ambulation Difficulties 1 1

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