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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
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
2017 91 91
2018 64 64
2019 78 78
2020 121 121
2021 384 384
2022 20 20

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 326 326
Appropriate Term/Code Not Available 106 106
Unstable 80 80
Fracture 58 58
Insufficient Information 48 48
Loss of or Failure to Bond 30 30
Loose or Intermittent Connection 18 18
Difficult to Insert 17 17
Naturally Worn 15 15
Noise, Audible 14 14
Loosening of Implant Not Related to Bone-Ingrowth 11 11
Device Contaminated During Manufacture or Shipping 9 9
Migration or Expulsion of Device 8 8
Device Dislodged or Dislocated 7 7
Migration 7 7
Patient Device Interaction Problem 6 6
Tear, Rip or Hole in Device Packaging 5 5
Use of Device Problem 4 4
Detachment of Device or Device Component 4 4
Off-Label Use 4 4
Inadequacy of Device Shape and/or Size 4 4
Device Operates Differently Than Expected 3 3
Fitting Problem 3 3
Device Damaged Prior to Use 3 3
Component Missing 3 3
Defective Device 3 3
Patient-Device Incompatibility 3 3
Packaging Problem 3 3
Residue After Decontamination 2 2
Device Packaging Compromised 2 2
Difficult to Open or Remove Packaging Material 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Device Slipped 2 2
Difficult or Delayed Positioning 2 2
Break 2 2
Contamination 1 1
Crack 1 1
Degraded 1 1
Positioning Failure 1 1
Material Too Rigid or Stiff 1 1
Pitted 1 1
Mechanical Problem 1 1
Material Deformation 1 1
Excessive Cooling 1 1
Device Contamination with Chemical or Other Material 1 1
Device Markings/Labelling Problem 1 1
Failure to Align 1 1
Device Fell 1 1
Incomplete or Inadequate Connection 1 1
Inaccurate Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 219 219
Unspecified Infection 84 84
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 84 84
Joint Laxity 75 75
No Code Available 68 68
Loss of Range of Motion 56 56
Insufficient Information 49 49
No Known Impact Or Consequence To Patient 45 45
Adhesion(s) 45 45
No Information 41 41
Fall 35 35
Muscular Rigidity 33 33
Failure of Implant 30 30
No Clinical Signs, Symptoms or Conditions 24 24
Limited Mobility Of The Implanted Joint 23 23
Synovitis 22 22
Ambulation Difficulties 18 18
Swelling/ Edema 17 17
Swelling 17 17
No Patient Involvement 14 14
Osteolysis 12 12
Scar Tissue 12 12
Discomfort 10 10
Inflammation 10 10
No Consequences Or Impact To Patient 8 8
Bone Fracture(s) 6 6
Injury 5 5
Necrosis 5 5
Reaction 5 5
Joint Dislocation 5 5
Cancer 5 5
Claudication 4 4
Metal Related Pathology 4 4
Hematoma 4 4
Cyst(s) 4 4
Wound Dehiscence 4 4
Ossification 3 3
Edema 3 3
Embolism 3 3
Hypersensitivity/Allergic reaction 3 3
Granuloma 3 3
Fatigue 2 2
Foreign Body Reaction 2 2
Joint Swelling 2 2
Muscle/Tendon Damage 2 2
Limb Fracture 2 2
Weight Changes 2 2
Fluid Discharge 2 2
Thrombosis/Thrombus 1 1
Blood Loss 1 1
Impaired Healing 1 1
Numbness 1 1
Neck Stiffness 1 1
Post Operative Wound Infection 1 1
Sleep Dysfunction 1 1
Joint Contracture 1 1
Unspecified Tissue Injury 1 1
Disability 1 1
Joint Disorder 1 1
Arthralgia 1 1
Rupture 1 1
Weakness 1 1
Rash 1 1
Scarring 1 1
Sepsis 1 1
Damage to Ligament(s) 1 1
Syncope 1 1
Abrasion 1 1

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