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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
BIOMET MANUFACTURING CORP.
  SUBSTANTIALLY EQUIVALENT 1
DEPUY ORTHOPAEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 4
ENCORE MEDICAL, L.P.
  SUBSTANTIALLY EQUIVALENT 4
RENOVIS SURGICAL TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 84 84
2015 282 282
2016 129 129
2017 91 91
2018 64 64
2019 78 78
2020 121 121
2021 383 383
2022 42 42
2023 39 39
2024 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 412 412
Insufficient Information 256 256
Appropriate Term/Code Not Available 146 146
Unstable 132 132
Failure To Adhere Or Bond 104 104
Fracture 62 62
Loss of or Failure to Bond 32 32
Loose or Intermittent Connection 31 31
Difficult to Insert 26 26
Migration or Expulsion of Device 20 20
Device Operates Differently Than Expected 18 18
Naturally Worn 17 17
Noise, Audible 16 16
Device Dislodged or Dislocated 15 15
Break 14 14
Inadequacy of Device Shape and/or Size 13 13
Loosening of Implant Not Related to Bone-Ingrowth 11 11
Device Contaminated During Manufacture or Shipping 9 9
Migration 8 8
Patient Device Interaction Problem 6 6
Malposition of Device 6 6
Device Slipped 6 6
Tear, Rip or Hole in Device Packaging 5 5
Component Missing 4 4
Fitting Problem 4 4
Off-Label Use 4 4
Use of Device Problem 4 4
Nonstandard Device 4 4
Patient-Device Incompatibility 4 4
Detachment of Device or Device Component 4 4
Defective Device 4 4
Packaging Problem 3 3
Contamination 3 3
Device Damaged Prior to Use 3 3
Sticking 2 2
Difficult or Delayed Positioning 2 2
Detachment Of Device Component 2 2
Disassembly 2 2
Positioning Problem 2 2
Osseointegration Problem 2 2
Device Packaging Compromised 2 2
Difficult to Open or Remove Packaging Material 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Residue After Decontamination 2 2
Device Contamination with Chemical or Other Material 2 2
Excessive Cooling 1 1
Failure of Device to Self-Test 1 1
Material Deformation 1 1
Material Integrity Problem 1 1
Device Displays Incorrect Message 1 1
Device Markings/Labelling Problem 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Device Fell 1 1
Incomplete or Inadequate Connection 1 1
Inaccurate Information 1 1
Scratched Material 1 1
Therapeutic or Diagnostic Output Failure 1 1
Material Erosion 1 1
Pitted 1 1
Difficult To Position 1 1
Positioning Failure 1 1
Crack 1 1
Degraded 1 1
Out-Of-Box Failure 1 1
Failure to Align 1 1
Metal Shedding Debris 1 1
Improper or Incorrect Procedure or Method 1 1
Radio Signal Problem 1 1
Material Too Rigid or Stiff 1 1
Incorrect Measurement 1 1
Mechanical Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 416 416
Unspecified Infection 168 168
No Code Available 154 154
No Information 141 141
Joint Laxity 99 99
Loss of Range of Motion 86 86
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 84 84
No Known Impact Or Consequence To Patient 67 67
Insufficient Information 55 55
Adhesion(s) 47 47
Swelling 46 46
Fall 43 43
Failure of Implant 39 39
Muscular Rigidity 34 34
Limited Mobility Of The Implanted Joint 32 32
Scar Tissue 26 26
Ambulation Difficulties 25 25
No Clinical Signs, Symptoms or Conditions 24 24
Synovitis 23 23
Swelling/ Edema 19 19
Discomfort 16 16
Osteolysis 16 16
No Patient Involvement 14 14
Joint Dislocation 11 11
Inflammation 11 11
Bone Fracture(s) 9 9
No Consequences Or Impact To Patient 9 9
Wound Dehiscence 8 8
Reaction 7 7
Scarring 6 6
Injury 6 6
Claudication 5 5
Cancer 5 5
Cyst(s) 5 5
Hematoma 5 5
Necrosis 5 5
Hypersensitivity/Allergic reaction 5 5
Implant Pain 5 5
Metal Related Pathology 5 5
Fibrosis 4 4
Joint Disorder 4 4
Complaint, Ill-Defined 4 4
Joint Swelling 3 3
Granuloma 3 3
Foreign Body Reaction 3 3
Edema 3 3
Embolism 3 3
Ossification 3 3
Muscle/Tendon Damage 3 3
Limb Fracture 2 2
Bruise/Contusion 2 2
Arthralgia 2 2
Fluid Discharge 2 2
Sleep Dysfunction 2 2
Weight Changes 2 2
Numbness 2 2
Neck Stiffness 1 1
Post Operative Wound Infection 1 1
Blood Loss 1 1
Foreign Body In Patient 1 1
Inadequate Osseointegration 1 1
Thrombosis/Thrombus 1 1
Disability 1 1
Impaired Healing 1 1
Inadequate Pain Relief 1 1
Sepsis 1 1
Rupture 1 1
Discharge 1 1
Myalgia 1 1
Fatigue 1 1
Hemorrhage/Bleeding 1 1
Syncope 1 1
Abrasion 1 1
Bacterial Infection 1 1
Nerve Damage 1 1
Irritation 1 1
Damage to Ligament(s) 1 1
Thrombus 1 1
Weakness 1 1
Rash 1 1
Retinal Tear 1 1
Joint Contracture 1 1
Unspecified Tissue Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Conformis, Inc. II Feb-13-2023
2 DePuy Orthopaedics, Inc. II Mar-17-2023
3 Encore Medical, Lp II Oct-26-2015
4 Encore Medical, Lp II May-02-2013
5 Encore Medical, Lp II Aug-30-2012
6 Zimmer, Inc. II Feb-04-2015
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