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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


Premarket Reviews
ManufacturerDecision
ENCORE MEDICAL, L.P.
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 479 479
2018 281 281
2019 534 534
2020 287 287
2021 215 215
2022 141 141

Device Problems MDRs with this Device Problem Events in those MDRs
Device Dislodged or Dislocated 773 773
Adverse Event Without Identified Device or Use Problem 284 284
Insufficient Information 279 279
Naturally Worn 146 146
Fracture 132 132
Appropriate Term/Code Not Available 81 81
Device Contaminated During Manufacture or Shipping 66 66
Break 43 43
Detachment of Device or Device Component 37 37
Migration or Expulsion of Device 36 36
Difficult to Insert 32 32
Loose or Intermittent Connection 22 22
Unstable 22 22
Noise, Audible 18 18
Disassembly 17 17
Packaging Problem 15 15
Nonstandard Device 14 14
Scratched Material 13 13
Material Deformation 12 12
Material Erosion 11 11
Loss of or Failure to Bond 11 11
Positioning Failure 11 11
Off-Label Use 10 10
Loss of Osseointegration 10 10
Separation Failure 10 10
Malposition of Device 10 10
Loosening of Implant Not Related to Bone-Ingrowth 10 10
Unintended Movement 8 8
Fitting Problem 8 8
Corroded 8 8
Migration 7 7
Inadequacy of Device Shape and/or Size 6 6
Tear, Rip or Hole in Device Packaging 6 6
Positioning Problem 6 6
Device-Device Incompatibility 6 6
Material Twisted/Bent 5 5
Biocompatibility 5 5
Use of Device Problem 5 5
Mechanical Problem 5 5
Difficult to Remove 4 4
Material Separation 4 4
Connection Problem 4 4
Failure to Osseointegrate 3 3
Component Missing 3 3
Device Damaged by Another Device 3 3
Shipping Damage or Problem 3 3
Device Difficult to Setup or Prepare 3 3
Metal Shedding Debris 2 2
Crack 2 2
Degraded 2 2
Device Operates Differently Than Expected 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Osseointegration Problem 2 2
Dent in Material 2 2
Improper or Incorrect Procedure or Method 2 2
Device Damaged Prior to Use 2 2
Deformation Due to Compressive Stress 2 2
Contamination /Decontamination Problem 2 2
Patient-Device Incompatibility 2 2
Defective Device 2 2
Illegible Information 2 2
Physical Resistance/Sticking 1 1
Difficult or Delayed Separation 1 1
Therapeutic or Diagnostic Output Failure 1 1
Patient Device Interaction Problem 1 1
Device Or Device Fragments Location Unknown 1 1
Defective Component 1 1
Failure to Disconnect 1 1
Device Contamination with Body Fluid 1 1
Mechanical Jam 1 1
Material Distortion 1 1
Material Integrity Problem 1 1
Excessive Cooling 1 1
Device Contamination with Chemical or Other Material 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
Entrapment of Device 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 637 637
No Code Available 536 536
Pain 278 278
Injury 212 212
Unspecified Infection 202 202
No Information 152 152
No Consequences Or Impact To Patient 68 68
Osteolysis 67 67
No Clinical Signs, Symptoms or Conditions 63 63
Not Applicable 61 61
No Known Impact Or Consequence To Patient 61 61
No Patient Involvement 56 56
Foreign Body Reaction 56 56
Insufficient Information 48 48
Fall 41 41
Failure of Implant 37 37
Tissue Damage 37 37
Test Result 37 37
Limited Mobility Of The Implanted Joint 33 33
Ambulation Difficulties 30 30
Loss of Range of Motion 28 28
Bone Fracture(s) 28 28
Discomfort 26 26
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 26 26
Hypersensitivity/Allergic reaction 23 23
Joint Laxity 21 21
Reaction 14 14
Hematoma 14 14
Inadequate Osseointegration 12 12
Ossification 11 11
Adhesion(s) 11 11
Thrombosis 11 11
Edema 10 10
Osteopenia/ Osteoporosis 10 10
Joint Disorder 9 9
Inflammation 9 9
Host-Tissue Reaction 9 9
Swelling 9 9
Scar Tissue 9 9
Necrosis 9 9
Weakness 8 8
Pulmonary Embolism 8 8
Cyst(s) 7 7
Death 7 7
Impaired Healing 7 7
Blood Loss 6 6
Fatigue 6 6
Hemorrhage/Bleeding 5 5
Wound Dehiscence 5 5
Hip Fracture 5 5
Peroneal Nerve Palsy 5 5
Metal Related Pathology 5 5
Unspecified Tissue Injury 5 5
Infarction, Cerebral 4 4
Erosion 4 4
Cardiac Arrest 4 4
Anxiety 3 3
Distress 3 3
Scarring 3 3
Respiratory Distress 3 3
Physical Asymmetry 3 3
Swelling/ Edema 3 3
Unspecified Musculoskeletal problem 3 3
Patient Problem/Medical Problem 3 3
Diaphoresis 2 2
Claudication 2 2
Numbness 2 2
Staphylococcus Aureus 2 2
Sepsis 2 2
Seroma 2 2
Nerve Damage 2 2
Nausea 2 2
Chills 2 2
Urinary Tract Infection 2 2
Bruise/Contusion 2 2
Bacterial Infection 2 2
Abscess 2 2
Arthritis 2 2
Atrial Fibrillation 1 1
Anemia 1 1
Debris, Bone Shedding 1 1
Calcium Deposits/Calcification 1 1
Cellulitis 1 1
Fever 1 1
Headache 1 1
Hearing Impairment 1 1
Hearing Loss 1 1
Ischemia 1 1
Damage to Ligament(s) 1 1
Muscle Spasm(s) 1 1
Muscle Weakness 1 1
Muscular Rigidity 1 1
High Blood Pressure/ Hypertension 1 1
Tingling 1 1
Synovitis 1 1
Thrombus 1 1
Hypoesthesia 1 1
Arthralgia 1 1
Deformity/ Disfigurement 1 1
Neurological Deficit/Dysfunction 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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