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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 26 26

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 83 83
Insufficient Information 39 39
Loss of Osseointegration 28 28
Difficult to Insert 18 18
Osseointegration Problem 17 17
Fracture 14 14
Degraded 11 11
Material Discolored 11 11
Migration 11 11
Naturally Worn 10 10
Appropriate Term/Code Not Available 9 9
Device Difficult to Setup or Prepare 8 8
Device Dislodged or Dislocated 8 8
Loss of or Failure to Bond 7 7
Unstable 6 6
Use of Device Problem 4 4
Unintended Movement 3 3
Inadequacy of Device Shape and/or Size 3 3
Device Damaged Prior to Use 2 2
Positioning Problem 2 2
Loosening of Implant Not Related to Bone-Ingrowth 2 2
Failure to Osseointegrate 2 2
Detachment of Device or Device Component 2 2
Break 1 1
Off-Label Use 1 1
Material Disintegration 1 1
Material Erosion 1 1
Positioning Failure 1 1
Loose or Intermittent Connection 1 1
Biocompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 86 86
Insufficient Information 54 54
Inadequate Osseointegration 40 40
Unspecified Infection 39 39
No Clinical Signs, Symptoms or Conditions 35 35
Injury 27 27
Ambulation Difficulties 14 14
Fall 10 10
Joint Laxity 9 9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Bone Fracture(s) 5 5
Loss of Range of Motion 5 5
No Code Available 4 4
No Known Impact Or Consequence To Patient 4 4
Joint Dislocation 3 3
Osteolysis 3 3
Fluid Discharge 3 3
Failure of Implant 2 2
Inflammation 2 2
Post Operative Wound Infection 2 2
Subluxation 2 2
Swelling/ Edema 2 2
Arthritis 2 2
Hypersensitivity/Allergic reaction 1 1
No Information 1 1
Adhesion(s) 1 1
Cyst(s) 1 1
Swelling 1 1
Discomfort 1 1
Muscular Rigidity 1 1
Unspecified Tissue Injury 1 1
Bacterial Infection 1 1

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