• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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


Premarket Reviews
ManufacturerDecision
ENCORE MEDICAL, L.P.
  SUBSTANTIALLY EQUIVALENT 2
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 1180 1180
2017 479 479
2018 281 281
2019 534 534
2020 287 287
2021 186 186

Device Problems MDRs with this Device Problem Events in those MDRs
Device Dislodged or Dislocated 952 952
Insufficient Information 842 842
Adverse Event Without Identified Device or Use Problem 267 267
Naturally Worn 168 168
Fracture 145 145
Appropriate Term/Code Not Available 131 131
Failure To Adhere Or Bond 103 103
Migration or Expulsion of Device 87 87
Break 67 67
Device Contaminated During Manufacture or Shipping 61 61
Corroded 52 52
Unstable 47 47
Difficult to Insert 36 36
Disassembly 31 31
Detachment of Device or Device Component 27 27
Malposition of Device 26 26
Loose or Intermittent Connection 22 22
Noise, Audible 19 19
Loss of Osseointegration 16 16
Packaging Problem 15 15
Nonstandard Device 14 14
Material Erosion 14 14
Detachment Of Device Component 13 13
Material Deformation 13 13
Scratched Material 13 13
Mechanical Problem 11 11
Loss of or Failure to Bond 11 11
Positioning Failure 10 10
Separation Failure 10 10
Fitting Problem 9 9
Compatibility Problem 8 8
Biocompatibility 7 7
Material Separation 7 7
Positioning Problem 7 7
Unintended Movement 6 6
Loosening of Implant Not Related to Bone-Ingrowth 6 6
Migration 6 6
Difficult to Remove 6 6
Inadequacy of Device Shape and/or Size 6 6
Crack 6 6
Device-Device Incompatibility 6 6
Tear, Rip or Hole in Device Packaging 5 5
Material Integrity Problem 5 5
Material Twisted/Bent 5 5
Failure to Osseointegrate 5 5
Use of Device Problem 5 5
Off-Label Use 5 5
Device Slipped 4 4
Osseointegration Problem 4 4
Connection Problem 4 4
Device Operates Differently Than Expected 4 4
Device Damaged by Another Device 4 4
Component Missing 3 3
Shipping Damage or Problem 3 3
Metal Shedding Debris 2 2
Misassembled 2 2
Material Disintegration 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
Dent in Material 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Material Distortion 1 1
Mechanical Jam 1 1
Excessive Cooling 1 1
Device Contamination with Chemical or Other Material 1 1
Failure to Disconnect 1 1
Device Or Device Fragments Location Unknown 1 1
Defective Component 1 1
Device Contamination with Body Fluid 1 1
Failure to Align 1 1
Failure to Advance 1 1
Entrapment of Device 1 1
Delivered as Unsterile Product 1 1
Device Difficult to Setup or Prepare 1 1
Problem with Sterilization 1 1
Material Rupture 1 1
Degraded 1 1
Difficult or Delayed Positioning 1 1
Bent 1 1
Disconnection 1 1
Physical Resistance/Sticking 1 1
Difficult or Delayed Separation 1 1
Illegible Information 1 1
Therapeutic or Diagnostic Output Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 820 820
Joint Dislocation 648 648
No Information 581 581
Pain 410 410
Unspecified Infection 274 274
Injury 241 241
Osteolysis 94 94
No Known Impact Or Consequence To Patient 76 76
No Consequences Or Impact To Patient 73 73
Reaction 64 64
Not Applicable 61 61
Bone Fracture(s) 59 59
Foreign Body Reaction 58 58
No Patient Involvement 56 56
Fall 47 47
No Clinical Signs, Symptoms or Conditions 41 41
Limited Mobility Of The Implanted Joint 39 39
Tissue Damage 38 38
Test Result 37 37
Discomfort 33 33
Failure of Implant 31 31
Ambulation Difficulties 30 30
Hip Fracture 28 28
Loss of Range of Motion 27 27
Hematoma 25 25
Insufficient Information 24 24
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 23 23
Hypersensitivity/Allergic reaction 22 22
Ossification 20 20
Swelling 20 20
Thrombosis 16 16
Pulmonary Embolism 14 14
Death 14 14
Edema 14 14
Inflammation 13 13
Inadequate Osseointegration 13 13
Host-Tissue Reaction 12 12
Erosion 10 10
Necrosis 10 10
Joint Disorder 10 10
Joint Laxity 9 9
Adhesion(s) 9 9
Weakness 8 8
Osteopenia/ Osteoporosis 8 8
Impaired Healing 8 8
Blood Loss 7 7
Scar Tissue 7 7
Cyst(s) 6 6
Hemorrhage/Bleeding 6 6
Fatigue 5 5
Wound Dehiscence 5 5
Cardiac Arrest 5 5
Nerve Damage 5 5
Numbness 5 5
Peroneal Nerve Palsy 5 5
Patient Problem/Medical Problem 4 4
Claudication 4 4
Respiratory Distress 4 4
Sepsis 4 4
Infarction, Cerebral 4 4
Abscess 4 4
Arthritis 3 3
Bruise/Contusion 3 3
Synovitis 3 3
Heart Failure 3 3
Anxiety 3 3
Scarring 3 3
Staphylococcus Aureus 2 2
Local Reaction 2 2
Pneumonia 2 2
Neurological Deficit/Dysfunction 2 2
Ischemia 2 2
Nausea 2 2
Chills 2 2
Seroma 2 2
Urinary Tract Infection 2 2
Bacterial Infection 2 2
Anemia 2 2
Metal Related Pathology 2 2
Sleep Dysfunction 2 2
Diaphoresis 2 2
Swelling/ Edema 2 2
Sudden Cardiac Death 1 1
Post Operative Wound Infection 1 1
Non-union Bone Fracture 1 1
Disability 1 1
Toxicity 1 1
Hypoesthesia 1 1
Arthralgia 1 1
Physical Asymmetry 1 1
Limb Fracture 1 1
Device Embedded In Tissue or Plaque 1 1
Fibrosis 1 1
Atrial Fibrillation 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

Recalls
Manufacturer Recall Class Date Posted
1 Encore Medical, Lp II Apr-10-2019
-
-