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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device prosthesis, hip, constrained, cemented or uncemented, metal/polymer
Product CodeKWZ
Regulation Number 888.3310
Device Class 2

MDR Year MDR Reports MDR Events
2019 533 533
2020 288 288
2021 216 216
2022 158 158
2023 162 162
2024 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Device Dislodged or Dislocated 584 584
Adverse Event Without Identified Device or Use Problem 293 293
Naturally Worn 127 127
Fracture 114 114
Device Contaminated During Manufacture or Shipping 68 68
Insufficient Information 55 55
Appropriate Term/Code Not Available 48 48
Detachment of Device or Device Component 43 43
Difficult to Insert 28 28
Unstable 23 23
Break 22 22
Noise, Audible 16 16
Packaging Problem 15 15
Positioning Failure 12 12
Loose or Intermittent Connection 11 11
Off-Label Use 11 11
Material Deformation 11 11
Loosening of Implant Not Related to Bone-Ingrowth 10 10
Nonstandard Device 10 10
Scratched Material 9 9
Unintended Movement 8 8
Device-Device Incompatibility 8 8
Separation Failure 7 7
Migration 7 7
Malposition of Device 7 7
Tear, Rip or Hole in Device Packaging 6 6
Loss of or Failure to Bond 6 6
Material Erosion 6 6
Difficult to Remove 5 5
Loss of Osseointegration 5 5
Biocompatibility 5 5
Use of Device Problem 5 5
Fitting Problem 5 5
Inadequacy of Device Shape and/or Size 5 5
Mechanical Problem 4 4
Patient Device Interaction Problem 4 4
Material Twisted/Bent 3 3
Connection Problem 3 3
Device Difficult to Setup or Prepare 3 3
Shipping Damage or Problem 3 3
Improper or Incorrect Procedure or Method 3 3
Component Missing 2 2
Deformation Due to Compressive Stress 2 2
Contamination /Decontamination Problem 2 2
Failure to Osseointegrate 2 2
Material Separation 2 2
Corroded 2 2
Osseointegration Problem 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Defective Device 2 2
Difficult to Open or Close 2 2
Illegible Information 2 2
Physical Resistance/Sticking 1 1
Difficult or Delayed Separation 1 1
Therapeutic or Diagnostic Output Failure 1 1
Positioning Problem 1 1
Excessive Cooling 1 1
Device Contamination with Chemical or Other Material 1 1
Device Damaged by Another Device 1 1
Mechanical Jam 1 1
Crack 1 1
Degraded 1 1
Material Disintegration 1 1
Delivered as Unsterile Product 1 1
Defective Component 1 1
Problem with Sterilization 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Joint Dislocation 503 503
No Code Available 431 431
Pain 201 201
Unspecified Infection 140 140
Injury 97 97
No Clinical Signs, Symptoms or Conditions 77 77
Insufficient Information 74 74
Osteolysis 57 57
No Patient Involvement 56 56
Foreign Body Reaction 54 54
No Information 43 43
Failure of Implant 40 40
Fall 38 38
No Known Impact Or Consequence To Patient 38 38
Joint Laxity 37 37
No Consequences Or Impact To Patient 33 33
Tissue Damage 32 32
Test Result 32 32
Ambulation Difficulties 29 29
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 28 28
Limited Mobility Of The Implanted Joint 26 26
Loss of Range of Motion 23 23
Hypersensitivity/Allergic reaction 23 23
Bone Fracture(s) 19 19
Discomfort 17 17
Not Applicable 17 17
Hematoma 14 14
Inflammation 11 11
Ossification 11 11
Scar Tissue 11 11
Adhesion(s) 10 10
Edema 10 10
Osteopenia/ Osteoporosis 10 10
Inadequate Osseointegration 9 9
Thrombosis 9 9
Swelling 7 7
Necrosis 7 7
Weakness 7 7
Pulmonary Embolism 7 7
Joint Disorder 7 7
Metal Related Pathology 7 7
Unspecified Tissue Injury 7 7
Cyst(s) 6 6
Fatigue 6 6
Impaired Healing 6 6
Reaction 6 6
Swelling/ Edema 5 5
Unspecified Musculoskeletal problem 4 4
Hemorrhage/Bleeding 4 4
Erosion 4 4
Wound Dehiscence 4 4
Host-Tissue Reaction 3 3
Cardiac Arrest 3 3
Infarction, Cerebral 3 3
Death 3 3
Anxiety 3 3
Distress 3 3
Hip Fracture 3 3
Patient Problem/Medical Problem 3 3
Muscle/Tendon Damage 3 3
Thrombosis/Thrombus 2 2
Physical Asymmetry 2 2
Respiratory Distress 2 2
Arthralgia 2 2
Nerve Damage 2 2
Nausea 2 2
Synovitis 2 2
Scarring 2 2
Seroma 2 2
Skin Discoloration 1 1
Thrombus 1 1
Local Reaction 1 1
Renal Failure 1 1
Pocket Erosion 1 1
Deformity/ Disfigurement 1 1
Blood Loss 1 1
Numbness 1 1
Hypoesthesia 1 1
Erythema 1 1
Bruise/Contusion 1 1
Calcium Deposits/Calcification 1 1
Abscess 1 1
Anemia 1 1
Arrhythmia 1 1
Arthritis 1 1
Atrial Fibrillation 1 1
Headache 1 1
Hearing Impairment 1 1
Itching Sensation 1 1
Muscle Weakness 1 1
Muscular Rigidity 1 1
High Blood Pressure/ Hypertension 1 1
Infiltration into Tissue 1 1
Implant Pain 1 1
Limb Fracture 1 1
Subluxation 1 1
Unequal Limb Length 1 1
Fluid Discharge 1 1
Fibrosis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Encore Medical, Lp II Apr-10-2019
2 Exactech, Inc. II Jan-18-2024
3 Exactech, Inc. II Sep-09-2022
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