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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, knee, femorotibial, unicompartmental/unicondylar, uncemented, porous-coated, metal/polymer
Definition Intended to replace part of a knee joint in order to relieve pain and restore knee function, for indications such as uni-compartmental osteoarthritis; inflammatory arthritis; traumatic arthritis; varus, valgus or flexion deformities; and revision surgery.
Product CodeNJD
Regulation Number 888.3535
Device Class 2


Premarket Reviews
ManufacturerDecision
ENGAGE UNI, LLC
  SUBSTANTIALLY EQUIVALENT 1
SMITH+NEPHEW, INC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 5 5
2022 34 34
2023 59 59

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 54 54
Failure to Osseointegrate 10 10
Fracture 6 6
Malposition of Device 5 5
Positioning Problem 5 5
Migration 4 4
Off-Label Use 3 3
Loosening of Implant Not Related to Bone-Ingrowth 2 2
Osseointegration Problem 2 2
Detachment of Device or Device Component 2 2
Crack 2 2
Flaked 1 1
Mechanical Problem 1 1
Deformation Due to Compressive Stress 1 1
Improper or Incorrect Procedure or Method 1 1
Loss of Osseointegration 1 1
Installation-Related Problem 1 1
Premature Separation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 49 49
Arthralgia 17 17
Failure of Implant 16 16
Inadequate Osseointegration 13 13
Insufficient Information 9 9
Discomfort 6 6
Deformity/ Disfigurement 6 6
Bone Fracture(s) 5 5
Unspecified Tissue Injury 5 5
No Clinical Signs, Symptoms or Conditions 5 5
Joint Dislocation 4 4
Joint Laxity 3 3
Foreign Body In Patient 3 3
Perforation 3 3
Device Embedded In Tissue or Plaque 2 2
Implant Pain 2 2
Abscess 2 2
Erosion 2 2
Ambulation Difficulties 1 1

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