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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, semi-constrained, cemented, polymer + additive/metal/polymer + additive
Regulation Description Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
Definition Indicated for: 1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. 2. Correction of varus, valgus, or posttraumatic deformity. 3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. For cemented use.
Product CodeOIY
Regulation Number 888.3560
Device Class 2


Premarket Reviews
ManufacturerDecision
DEPUY ORTHOPAEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 128 128
2017 91 91
2018 64 64
2019 77 77
2020 119 119
2021 226 226

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 224 224
Insufficient Information 103 103
Unstable 85 85
Appropriate Term/Code Not Available 83 83
Fracture 55 55
Failure To Adhere Or Bond 32 32
Loss of or Failure to Bond 23 23
Loose or Intermittent Connection 18 18
Migration or Expulsion of Device 16 16
Difficult to Insert 15 15
Naturally Worn 14 14
Noise, Audible 11 11
Loosening of Implant Not Related to Bone-Ingrowth 8 8
Device Dislodged or Dislocated 7 7
Inadequacy of Device Shape and/or Size 6 6
Migration 5 5
Device Operates Differently Than Expected 5 5
Defective Device 4 4
Detachment of Device or Device Component 4 4
Device Contaminated During Manufacture or Shipping 4 4
Fitting Problem 3 3
Packaging Problem 3 3
Patient-Device Incompatibility 3 3
Off-Label Use 3 3
Device Slipped 3 3
Component Missing 3 3
Device Packaging Compromised 2 2
Break 2 2
Patient Device Interaction Problem 2 2
Device Damaged Prior to Use 2 2
Residue After Decontamination 2 2
Tear, Rip or Hole in Device Packaging 2 2
Osseointegration Problem 2 2
Contamination 2 2
Difficult or Delayed Positioning 2 2
Sticking 1 1
Scratched Material 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Deformation 1 1
Malposition of Device 1 1
Device Markings/Labelling Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Incomplete or Inadequate Connection 1 1
Excessive Cooling 1 1
Crack 1 1
Degraded 1 1
Positioning Failure 1 1
Disassembly 1 1
Pitted 1 1
Difficult To Position 1 1
Mechanical Problem 1 1
Difficult to Open or Remove Packaging Material 1 1
Failure to Align 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 197 197
No Code Available 98 98
Unspecified Infection 76 76
No Information 68 68
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 56 56
No Known Impact Or Consequence To Patient 49 49
Joint Laxity 43 43
Loss of Range of Motion 41 41
Insufficient Information 32 32
Adhesion(s) 31 31
Muscular Rigidity 28 28
Fall 28 28
Failure of Implant 27 27
Swelling 26 26
Limited Mobility Of The Implanted Joint 26 26
Synovitis 16 16
No Patient Involvement 14 14
Osteolysis 10 10
No Clinical Signs, Symptoms or Conditions 10 10
Ambulation Difficulties 9 9
No Consequences Or Impact To Patient 8 8
Scar Tissue 8 8
Discomfort 7 7
Reaction 7 7
Swelling/ Edema 7 7
Inflammation 7 7
Joint Dislocation 6 6
Injury 6 6
Claudication 5 5
Cancer 5 5
Cyst(s) 4 4
Bone Fracture(s) 4 4
Granuloma 3 3
Ossification 3 3
Joint Disorder 3 3
Embolism 3 3
Hematoma 3 3
Hypersensitivity/Allergic reaction 3 3
Wound Dehiscence 3 3
Metal Related Pathology 2 2
Muscle/Tendon Damage 2 2
Weight Changes 2 2
Joint Swelling 2 2
Necrosis 2 2
Scarring 1 1
Complaint, Ill-Defined 1 1
Weakness 1 1
Syncope 1 1
Bruise/Contusion 1 1
Edema 1 1
Damage to Ligament(s) 1 1
Disability 1 1
Arthralgia 1 1
Impaired Healing 1 1
Post Operative Wound Infection 1 1
Blood Loss 1 1
Inadequate Osseointegration 1 1
Fibrosis 1 1
Limb Fracture 1 1
Unspecified Tissue Injury 1 1
Fluid Discharge 1 1
Abrasion 1 1
Fatigue 1 1
Rash 1 1
Sepsis 1 1
Numbness 1 1
Neck Stiffness 1 1
Sleep Dysfunction 1 1

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