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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

MDR Year MDR Reports MDR Events
2017 10 10
2018 2 2
2019 15 15
2020 8 8
2021 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Break 16 16
Compatibility Problem 12 12
Patient Device Interaction Problem 3 3
Loose or Intermittent Connection 2 2
Crack 1 1
Component Missing 1 1
Defective Device 1 1
Detachment of Device or Device Component 1 1
Device Dislodged or Dislocated 1 1
Material Separation 1 1
Application Network Problem 1 1
Device Fell 1 1
Failure To Adhere Or Bond 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 15 15
Limited Mobility Of The Implanted Joint 13 13
Patient Problem/Medical Problem 12 12
No Known Impact Or Consequence To Patient 12 12
Unspecified Infection 12 12
No Clinical Signs, Symptoms or Conditions 6 6
Joint Disorder 3 3
Insufficient Information 2 2
No Consequences Or Impact To Patient 2 2
Bone Fracture(s) 1 1
No Information 1 1

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