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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
Regulation Description Knee joint femorotibial (uni-compartmental) metal/polymer porous-coated uncemented prosthesis.
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
SMITH+NEPHEW, INC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 5 5
2022 34 34
2023 61 61
2024 14 14
2025 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 64 64
Failure to Osseointegrate 13 13
Loosening of Implant Not Related to Bone-Ingrowth 7 7
Fracture 6 6
Malposition of Device 5 5
Positioning Problem 5 5
Osseointegration Problem 4 4
Migration 4 4
Off-Label Use 3 3
Detachment of Device or Device Component 2 2
Crack 2 2
Loss of Osseointegration 2 2
Biocompatibility 1 1
Deformation Due to Compressive Stress 1 1
Device Dislodged or Dislocated 1 1
Installation-Related Problem 1 1
Flaked 1 1
Material Fragmentation 1 1
Premature Separation 1 1
Improper or Incorrect Procedure or Method 1 1
Mechanical Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 58 58
Failure of Implant 20 20
Inadequate Osseointegration 20 20
Arthralgia 20 20
Insufficient Information 12 12
Bone Fracture(s) 8 8
Deformity/ Disfigurement 7 7
Discomfort 6 6
Unspecified Tissue Injury 5 5
No Clinical Signs, Symptoms or Conditions 5 5
Joint Dislocation 4 4
Hemorrhage/Bleeding 3 3
Joint Laxity 3 3
Implant Pain 3 3
Foreign Body In Patient 3 3
Perforation 3 3
Loss of Range of Motion 3 3
Abscess 2 2
Erosion 2 2
Device Embedded In Tissue or Plaque 2 2
Ambulation Difficulties 2 2
Inflammation 1 1
Metal Related Pathology 1 1
Swelling/ Edema 1 1

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