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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device bone cement
Regulation Description Polymethylmethacrylate (PMMA) bone cement.
Product CodeLOD
Regulation Number 888.3027
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOMET
  SUBSTANTIALLY EQUIVALENT 2
BIOMET INC
  SUBSTANTIALLY EQUIVALENT 1
BIOMET INC.
  SUBSTANTIALLY EQUIVALENT 1
KULZER, LLC
  SUBSTANTIALLY EQUIVALENT 4
SYNTHES (USA) PRODUCTS LLC / MEDICAL DEVICE BUSINESS SERVICE
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 615 615
2017 815 815
2018 1294 1294
2019 2353 2353
2020 1323 1323
2021 54 54

Device Problems MDRs with this Device Problem Events in those MDRs
Loss of or Failure to Bond 3746 3746
Adverse Event Without Identified Device or Use Problem 784 784
Insufficient Information 393 393
Loosening of Implant Not Related to Bone-Ingrowth 288 288
Loose or Intermittent Connection 267 267
Loss of Osseointegration 195 195
Appropriate Term/Code Not Available 175 175
Unsealed Device Packaging 119 119
Migration or Expulsion of Device 111 111
Failure To Adhere Or Bond 94 94
Break 93 93
Device Operates Differently Than Expected 85 85
Packaging Problem 70 70
Chemical Problem 62 62
Device Difficult to Setup or Prepare 57 57
Tear, Rip or Hole in Device Packaging 54 54
Device Damaged Prior to Use 48 48
Fracture 38 38
Unstable 34 34
Migration 32 32
Improper Chemical Reaction 26 26
Leak/Splash 26 26
Osseointegration Problem 25 25
Shipping Damage or Problem 25 25
Manufacturing, Packaging or Shipping Problem 20 20
Patient Device Interaction Problem 19 19
Device Packaging Compromised 18 18
Defective Device 18 18
Device Emits Odor 18 18
Device Contaminated During Manufacture or Shipping 18 18
Use of Device Problem 17 17
Infusion or Flow Problem 17 17
Delivered as Unsterile Product 16 16
Noise, Audible 14 14
Fluid Leak 12 12
Material Integrity Problem 12 12
Device Contamination with Chemical or Other Material 11 11
Material Deformation 9 9
Mechanical Problem 9 9
Device Dislodged or Dislocated 9 9
Difficult to Open or Remove Packaging Material 8 8
Expiration Date Error 8 8
Device Handling Problem 8 8
Missing Information 8 8
Improper or Incorrect Procedure or Method 7 7
Clumping in Device or Device Ingredient 7 7
Naturally Worn 7 7
Failure to Osseointegrate 7 7
Out-Of-Box Failure 6 6
Material Discolored 6 6
Contamination /Decontamination Problem 6 6
Physical Resistance/Sticking 5 5
Unintended Movement 5 5
Crack 5 5
Patient-Device Incompatibility 5 5
Component Missing 4 4
No Apparent Adverse Event 4 4
Failure to Eject 4 4
Material Fragmentation 4 4
Incomplete or Missing Packaging 4 4
Inadequate or Insufficient Training 4 4
Device Slipped 4 4
Contamination of Device Ingredient or Reagent 4 4
Contamination 4 4
Malposition of Device 4 4
Product Quality Problem 4 4
Failure to Advance 3 3
Sharp Edges 3 3
Material Too Rigid or Stiff 3 3
Disassembly 3 3
Material Split, Cut or Torn 3 3
Therapeutic or Diagnostic Output Failure 3 3
Detachment of Device or Device Component 3 3
Material Twisted/Bent 3 3
Device Operational Issue 2 2
Fumes or Vapors 2 2
Torn Material 2 2
Optical Discoloration 2 2
Activation Problem 2 2
Device Expiration Issue 2 2
Premature Activation 2 2
Material Separation 2 2
Scratched Material 2 2
Device Ingredient or Reagent Problem 2 2
Device Markings/Labelling Problem 2 2
Compatibility Problem 2 2
Defective Component 2 2
Sticking 2 2
Moisture Damage 2 2
Difficult to Insert 2 2
Disconnection 2 2
Entrapment of Device 1 1
Material Erosion 1 1
Misassembled 1 1
Coagulation in Device or Device Ingredient 1 1
Detachment Of Device Component 1 1
Computer Software Problem 1 1
Failure to Back-Up 1 1
Backflow 1 1
Partial Blockage 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 3525 3525
Pain 2866 2866
No Consequences Or Impact To Patient 721 721
No Information 553 553
Edema 486 486
Not Applicable 455 455
Unspecified Infection 419 419
Adhesion(s) 392 392
No Known Impact Or Consequence To Patient 256 256
Swelling 193 193
Limited Mobility Of The Implanted Joint 183 183
Injury 177 178
Synovitis 138 138
Discomfort 123 123
Loss of Range of Motion 112 112
Joint Disorder 107 107
Osteolysis 104 104
Inflammation 83 83
Muscular Rigidity 82 82
No Patient Involvement 75 75
Ambulation Difficulties 68 68
Fall 67 67
Inadequate Osseointegration 66 66
Tissue Damage 54 54
Fibrosis 53 53
Hypersensitivity/Allergic reaction 46 46
Failure of Implant 42 42
Scar Tissue 40 40
Scarring 40 40
Weakness 40 40
Cardiac Arrest 38 38
Death 37 37
No Clinical Signs, Symptoms or Conditions 31 31
Thrombosis 31 31
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 29 29
Necrosis 29 29
Bone Fracture(s) 28 28
Insufficient Information 28 28
Pulmonary Embolism 28 28
Wound Dehiscence 28 28
Hematoma 25 25
Joint Laxity 25 25
Local Reaction 24 24
Cyst(s) 24 24
Foreign Body Reaction 23 23
Reaction 22 22
Swelling/ Edema 18 18
Hemorrhage/Bleeding 16 16
Deformity/ Disfigurement 16 16
Low Blood Pressure/ Hypotension 15 15
Joint Dislocation 14 14
Hypoesthesia 12 12
Joint Swelling 12 12
Blood Loss 12 12
Impaired Healing 11 11
Fever 11 11
Erythema 10 10
Hip Fracture 9 9
Thrombosis/Thrombus 9 9
Implant Pain 9 9
Fatigue 8 8
Sepsis 8 8
Post Operative Wound Infection 7 7
Patient Problem/Medical Problem 7 7
Burning Sensation 6 6
Cellulitis 6 6
Abscess 6 6
Low Oxygen Saturation 6 6
Bradycardia 5 5
Infarction, Cerebral 5 5
Laceration(s) 5 5
Myocardial Infarction 5 5
Pocket Erosion 5 5
Anxiety 5 5
Arthralgia 5 5
Foreign Body In Patient 5 5
Depression 4 4
Respiratory Distress 4 4
Pulmonary Edema 4 4
Nerve Damage 4 4
Ossification 4 4
Dyspnea 4 4
Rash 4 4
Muscle Weakness 4 4
Anemia 3 3
Erosion 3 3
Respiratory Failure 3 3
Ulcer 3 3
Fluid Discharge 3 3
Pneumonia 3 3
Nausea 3 3
Shock 3 3
Test Result 3 3
Device Embedded In Tissue or Plaque 3 3
Unspecified Tissue Injury 3 3
Non-union Bone Fracture 2 2
Disability 2 2
Urinary Tract Infection 2 2
Heart Failure 2 2
Hypoxia 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Encore Medical, Lp II Nov-06-2017
2 Encore Medical, Lp II Aug-19-2016
3 Smith & Nephew, Inc. II Jan-29-2021
4 Stryker Instruments Div. of Stryker Corporation II Mar-28-2018
5 Zimmer Biomet, Inc. II Apr-25-2017
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