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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, hip, constrained, cemented or uncemented, metal/polymer
Product CodeKWZ
Regulation Number 888.3310
Device Class 2

MDR Year MDR Reports MDR Events
2018 281 281
2019 534 534
2020 287 287
2021 216 216
2022 158 158
2023 53 53

Device Problems MDRs with this Device Problem Events in those MDRs
Device Dislodged or Dislocated 637 637
Adverse Event Without Identified Device or Use Problem 292 292
Naturally Worn 126 126
Insufficient Information 121 121
Fracture 119 119
Device Contaminated During Manufacture or Shipping 68 68
Appropriate Term/Code Not Available 59 59
Detachment of Device or Device Component 37 37
Difficult to Insert 30 30
Break 28 28
Unstable 21 21
Loose or Intermittent Connection 19 19
Noise, Audible 16 16
Packaging Problem 15 15
Positioning Failure 12 12
Nonstandard Device 11 11
Off-Label Use 10 10
Loosening of Implant Not Related to Bone-Ingrowth 10 10
Material Erosion 9 9
Material Deformation 9 9
Malposition of Device 9 9
Separation Failure 8 8
Fitting Problem 8 8
Disassembly 8 8
Loss of or Failure to Bond 7 7
Unintended Movement 7 7
Migration 7 7
Device-Device Incompatibility 6 6
Tear, Rip or Hole in Device Packaging 6 6
Loss of Osseointegration 6 6
Biocompatibility 5 5
Material Twisted/Bent 5 5
Migration or Expulsion of Device 5 5
Use of Device Problem 5 5
Inadequacy of Device Shape and/or Size 5 5
Difficult to Remove 4 4
Mechanical Problem 4 4
Corroded 4 4
Connection Problem 4 4
Positioning Problem 4 4
Scratched Material 4 4
Device Difficult to Setup or Prepare 3 3
Component Missing 3 3
Material Separation 3 3
Shipping Damage or Problem 3 3
Failure to Osseointegrate 3 3
Improper or Incorrect Procedure or Method 3 3
Crack 2 2
Degraded 2 2
Device Damaged Prior to Use 2 2
Deformation Due to Compressive Stress 2 2
Contamination /Decontamination Problem 2 2
Defective Device 2 2
Patient-Device Incompatibility 2 2
Osseointegration Problem 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Patient Device Interaction Problem 2 2
Illegible Information 2 2
Physical Resistance/Sticking 1 1
Difficult or Delayed Separation 1 1
Mechanical Jam 1 1
Excessive Cooling 1 1
Device Contamination with Chemical or Other Material 1 1
Therapeutic or Diagnostic Output Failure 1 1
Device Or Device Fragments Location Unknown 1 1
Device Damaged by Another Device 1 1
Defective Component 1 1
Dent in Material 1 1
Failure to Disconnect 1 1
Difficult or Delayed Positioning 1 1
Detachment Of Device Component 1 1
Failure To Adhere Or Bond 1 1
Bent 1 1
Disconnection 1 1
Material Disintegration 1 1
Metal Shedding Debris 1 1
Problem with Sterilization 1 1
Material Rupture 1 1
Delivered as Unsterile Product 1 1
Misassembled 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Joint Dislocation 556 556
No Code Available 475 475
Pain 225 225
Unspecified Infection 165 165
Injury 138 138
No Clinical Signs, Symptoms or Conditions 67 67
Osteolysis 62 62
Not Applicable 59 59
No Information 57 57
Insufficient Information 57 57
No Patient Involvement 56 56
Foreign Body Reaction 53 53
No Known Impact Or Consequence To Patient 50 50
No Consequences Or Impact To Patient 50 50
Test Result 37 37
Tissue Damage 36 36
Fall 36 36
Failure of Implant 35 35
Ambulation Difficulties 30 30
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 28 28
Joint Laxity 28 28
Limited Mobility Of The Implanted Joint 27 27
Loss of Range of Motion 26 26
Hypersensitivity/Allergic reaction 22 22
Discomfort 19 19
Bone Fracture(s) 19 19
Hematoma 14 14
Adhesion(s) 12 12
Scar Tissue 10 10
Inadequate Osseointegration 10 10
Edema 10 10
Osteopenia/ Osteoporosis 10 10
Necrosis 9 9
Ossification 9 9
Thrombosis 9 9
Inflammation 8 8
Reaction 8 8
Joint Disorder 8 8
Weakness 7 7
Impaired Healing 7 7
Pulmonary Embolism 7 7
Swelling 7 7
Cyst(s) 6 6
Unspecified Tissue Injury 6 6
Fatigue 6 6
Blood Loss 6 6
Metal Related Pathology 5 5
Wound Dehiscence 4 4
Host-Tissue Reaction 4 4
Cardiac Arrest 4 4
Distress 4 4
Infarction, Cerebral 4 4
Swelling/ Edema 4 4
Hemorrhage/Bleeding 4 4
Erosion 4 4
Patient Problem/Medical Problem 3 3
Scarring 3 3
Hip Fracture 3 3
Unspecified Musculoskeletal problem 3 3
Anxiety 3 3
Death 3 3
Nausea 2 2
Chills 2 2
Respiratory Distress 2 2
Muscle/Tendon Damage 2 2
Synovitis 2 2
Physical Asymmetry 2 2
Seroma 2 2
Urinary Tract Infection 2 2
Diaphoresis 2 2
Renal Failure 1 1
Hypoesthesia 1 1
Local Reaction 1 1
Damage to Ligament(s) 1 1
Bacterial Infection 1 1
Bruise/Contusion 1 1
Abscess 1 1
Calcium Deposits/Calcification 1 1
High Blood Pressure/ Hypertension 1 1
Thrombus 1 1
Atrial Fibrillation 1 1
Headache 1 1
Nerve Damage 1 1
Unequal Limb Length 1 1
Anemia 1 1
Deformity/ Disfigurement 1 1
Hearing Impairment 1 1
Infiltration into Tissue 1 1
Muscle Weakness 1 1
Skin Discoloration 1 1
Pocket Erosion 1 1
Post Operative Wound Infection 1 1
Fibrosis 1 1
Limb Fracture 1 1
Arthritis 1 1
Muscle Spasm(s) 1 1
Arthralgia 1 1
Arrhythmia 1 1
Muscular Rigidity 1 1
Implant Pain 1 1

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