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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 INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 1
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 118 118
2021 116 116

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 158 158
Insufficient Information 103 103
Unstable 79 79
Appropriate Term/Code Not Available 65 65
Fracture 53 53
Failure To Adhere Or Bond 32 32
Loss of or Failure to Bond 16 16
Migration or Expulsion of Device 16 16
Loose or Intermittent Connection 16 16
Difficult to Insert 14 14
Naturally Worn 11 11
Noise, Audible 10 10
Device Dislodged or Dislocated 7 7
Inadequacy of Device Shape and/or Size 6 6
Loosening of Implant Not Related to Bone-Ingrowth 6 6
Device Operates Differently Than Expected 5 5
Migration 4 4
Packaging Problem 3 3
Patient-Device Incompatibility 3 3
Device Contaminated During Manufacture or Shipping 3 3
Fitting Problem 3 3
Defective Device 3 3
Component Missing 3 3
Device Slipped 3 3
Difficult or Delayed Positioning 2 2
Break 2 2
Contamination 2 2
Residue After Decontamination 2 2
Tear, Rip or Hole in Device Packaging 2 2
Device Damaged Prior to Use 2 2
Detachment of Device or Device Component 2 2
Device Packaging Compromised 2 2
Osseointegration Problem 2 2
Patient Device Interaction Problem 2 2
Scratched Material 1 1
Incomplete or Inadequate Connection 1 1
Device Markings/Labelling Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Deformation 1 1
Excessive Cooling 1 1
Device Contamination with Chemical or Other Material 1 1
Malposition of Device 1 1
Failure to Align 1 1
Crack 1 1
Degraded 1 1
Positioning Failure 1 1
Disassembly 1 1
Sticking 1 1
Mechanical Problem 1 1
Pitted 1 1
Difficult To Position 1 1
Off-Label Use 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 165 165
No Code Available 97 97
No Information 68 68
Unspecified Infection 62 62
No Known Impact Or Consequence To Patient 49 49
Loss of Range of Motion 32 32
Joint Laxity 27 27
Limited Mobility Of The Implanted Joint 26 26
Swelling 26 26
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 26 26
Failure of Implant 24 24
Fall 23 23
Insufficient Information 23 23
Adhesion(s) 22 22
Muscular Rigidity 21 21
No Patient Involvement 14 14
Synovitis 12 12
Scar Tissue 8 8
Reaction 8 8
No Consequences Or Impact To Patient 8 8
Ambulation Difficulties 8 8
Osteolysis 8 8
Joint Dislocation 6 6
Injury 6 6
Swelling/ Edema 5 5
Discomfort 5 5
Claudication 5 5
Cancer 5 5
Inflammation 4 4
Bone Fracture(s) 4 4
Embolism 3 3
Ossification 3 3
Joint Disorder 3 3
Hypersensitivity/Allergic reaction 3 3
No Clinical Signs, Symptoms or Conditions 3 3
Hematoma 2 2
Wound Dehiscence 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
Post Operative Wound Infection 1 1
Blood Loss 1 1
Limb Fracture 1 1
Inadequate Osseointegration 1 1
Fibrosis 1 1
Abrasion 1 1
Cyst(s) 1 1
Rash 1 1
Sepsis 1 1
Fluid Discharge 1 1
Numbness 1 1
Neck Stiffness 1 1
Sleep Dysfunction 1 1

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