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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, knee patellofemorotibial, partial, semi-constrained, cemented, polymer/metal/polymer
Regulation Description Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
Definition The device is intended to replace the medial condyle and the patellofemoral compartment of the distal femur with a single device. The device is meant to be used with a uni-compartmental tibial base and insert and a resurfacing patella. The device is intended to be used with bone cement.
Product CodeNPJ
Regulation Number 888.3560
Device Class 2

MDR Year MDR Reports MDR Events
2021 51 53
2022 32 32
2023 52 52
2024 44 44
2025 49 49
2026 19 19

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 94 96
Difficult to Insert 23 23
Fracture 20 20
Osseointegration Problem 18 18
Loss of Osseointegration 17 17
Insufficient Information 16 16
Degraded 15 15
Material Discolored 11 11
Migration 11 11
Loss of or Failure to Bond 10 10
Naturally Worn 9 9
Device Dislodged or Dislocated 7 7
Appropriate Term/Code Not Available 7 7
Unstable 6 6
Use of Device Problem 4 4
Unintended Movement 3 3
Device Difficult to Setup or Prepare 3 3
Off-Label Use 2 2
Malposition of Device 2 2
Device Damaged Prior to Use 2 2
Detachment of Device or Device Component 2 2
Positioning Problem 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Positioning Failure 1 1
Inadequacy of Device Shape and/or Size 1 1
Biocompatibility 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 79 80
Insufficient Information 67 67
Unspecified Infection 36 37
No Clinical Signs, Symptoms or Conditions 32 32
Inadequate Osseointegration 31 32
Ambulation Difficulties 11 11
Fall 9 10
Joint Laxity 8 8
Bone Fracture(s) 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Inflammation 5 5
Loss of Range of Motion 5 5
Osteolysis 3 3
Fluid Discharge 3 3
Swelling/ Edema 3 3
Discomfort 2 3
Subluxation 2 2
Arthritis 2 2
Hypersensitivity/Allergic reaction 1 1
Joint Dislocation 1 1
Adhesion(s) 1 1
Cyst(s) 1 1
Post Operative Wound Infection 1 1
Muscular Rigidity 1 1
Unspecified Tissue Injury 1 1

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