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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
2020 65 65
2021 51 51
2022 32 32
2023 52 52
2024 44 44
2025 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 79 79
Insufficient Information 37 37
Loss of Osseointegration 27 27
Fracture 14 14
Difficult to Insert 13 13
Osseointegration Problem 11 11
Migration 11 11
Material Discolored 11 11
Degraded 10 10
Appropriate Term/Code Not Available 9 9
Naturally Worn 9 9
Device Difficult to Setup or Prepare 8 8
Device Dislodged or Dislocated 7 7
Loss of or Failure to Bond 6 6
Unstable 5 5
Use of Device Problem 4 4
Inadequacy of Device Shape and/or Size 3 3
Unintended Movement 3 3
Device Damaged Prior to Use 2 2
Loosening of Implant Not Related to Bone-Ingrowth 2 2
Positioning Problem 2 2
Failure to Osseointegrate 2 2
Detachment of Device or Device Component 1 1
Off-Label Use 1 1
Biocompatibility 1 1
Material Disintegration 1 1
Break 1 1
Positioning Failure 1 1
Material Erosion 1 1
Loose or Intermittent Connection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 85 85
Insufficient Information 46 46
Unspecified Infection 36 36
Inadequate Osseointegration 33 33
No Clinical Signs, Symptoms or Conditions 31 31
Injury 27 27
Ambulation Difficulties 13 13
Fall 10 10
Joint Laxity 8 8
Loss of Range of Motion 5 5
Bone Fracture(s) 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
No Known Impact Or Consequence To Patient 4 4
No Code Available 4 4
Joint Dislocation 3 3
Fluid Discharge 3 3
Post Operative Wound Infection 2 2
Swelling/ Edema 2 2
Failure of Implant 2 2
Inflammation 2 2
Subluxation 2 2
Arthritis 2 2
Discomfort 1 1
Bacterial Infection 1 1
Adhesion(s) 1 1
Cyst(s) 1 1
Unspecified Tissue Injury 1 1
Swelling 1 1
Muscular Rigidity 1 1
Hypersensitivity/Allergic reaction 1 1
No Information 1 1

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