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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
Regulation Description Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.
Product CodeKWY
Regulation Number 888.3390
Device Class 2


Premarket Reviews
ManufacturerDecision
CORIN USA LIMITED
  SUBSTANTIALLY EQUIVALENT 1
KULZER, LLC
  SUBSTANTIALLY EQUIVALENT 1
ONKOS SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
UNITED ORTHOPEDIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER GMBH
  SUBSTANTIALLY EQUIVALENT 2
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2016 884 884
2017 834 834
2018 1395 1395
2019 1534 1534
2020 1289 1289
2021 60 60

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1627 1627
Insufficient Information 1338 1338
Device Dislodged or Dislocated 1149 1149
Naturally Worn 561 561
Appropriate Term/Code Not Available 483 483
Fracture 188 188
Loss of Osseointegration 146 146
Corroded 139 139
Noise, Audible 116 116
Material Erosion 86 86
Migration 84 84
Difficult to Insert 72 72
Metal Shedding Debris 72 72
Nonstandard Device 55 55
Break 54 54
Migration or Expulsion of Device 48 48
Malposition of Device 47 47
Loss of or Failure to Bond 45 45
Biocompatibility 39 39
Degraded 36 36
Osseointegration Problem 33 33
Disassembly 31 31
Device Contamination with Chemical or Other Material 30 30
Loose or Intermittent Connection 29 29
Use of Device Problem 28 28
Unintended Movement 27 27
Loosening of Implant Not Related to Bone-Ingrowth 26 26
Detachment of Device or Device Component 25 25
Unstable 23 23
Delivered as Unsterile Product 19 19
Device Contaminated During Manufacture or Shipping 17 17
Fitting Problem 17 17
Packaging Problem 14 14
Material Disintegration 14 14
Difficult to Remove 12 12
Device-Device Incompatibility 11 11
Inadequacy of Device Shape and/or Size 10 10
Detachment Of Device Component 10 10
Separation Failure 10 10
Patient-Device Incompatibility 10 10
Difficult To Position 8 8
Mechanical Problem 8 8
No Apparent Adverse Event 7 7
Patient Device Interaction Problem 7 7
Compatibility Problem 7 7
Scratched Material 6 6
Positioning Failure 6 6
Failure to Osseointegrate 6 6
Off-Label Use 5 5
Bent 5 5
Device Operates Differently Than Expected 5 5
Positioning Problem 5 5
Material Deformation 5 5
Device Markings/Labelling Problem 5 5
Contamination /Decontamination Problem 4 4
Device Difficult to Setup or Prepare 4 4
Device Slipped 4 4
Device Expiration Issue 3 3
Defective Device 3 3
Connection Problem 3 3
Tear, Rip or Hole in Device Packaging 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Failure To Adhere Or Bond 3 3
Material Integrity Problem 3 3
Physical Resistance/Sticking 2 2
Device Appears to Trigger Rejection 2 2
Improper or Incorrect Procedure or Method 2 2
Misassembled 2 2
Misconnection 2 2
Difficult or Delayed Positioning 2 2
Material Discolored 2 2
Dull, Blunt 2 2
Device Damaged Prior to Use 2 2
Device Damaged by Another Device 2 2
Device Packaging Compromised 2 2
Material Twisted/Bent 2 2
Mechanical Jam 2 2
Human-Device Interface Problem 2 2
Separation Problem 2 2
Material Separation 2 2
Component Missing 2 2
Expiration Date Error 1 1
Shipping Damage or Problem 1 1
Pitted 1 1
Material Too Rigid or Stiff 1 1
Device Abrasion From Instrument Or Another Object 1 1
Gradient Increase 1 1
Excess Flow or Over-Infusion 1 1
Incorrect Measurement 1 1
Screw 1 1
Heads 1 1
Plate 1 1
Crack 1 1
Inaccurate Information 1 1
Material Split, Cut or Torn 1 1
Installation-Related Problem 1 1
Material Protrusion/Extrusion 1 1
Device Operational Issue 1 1
Delamination 1 1
Activation, Positioning or SeparationProblem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 2488 2491
Pain 2235 2236
Joint Dislocation 919 920
Unspecified Infection 779 780
No Information 619 619
Test Result 545 545
Foreign Body Reaction 544 544
Injury 461 461
Osteolysis 325 325
Tissue Damage 319 319
Discomfort 308 308
Not Applicable 301 301
Limited Mobility Of The Implanted Joint 227 227
Inflammation 226 226
Host-Tissue Reaction 197 197
Bone Fracture(s) 191 191
Hypersensitivity/Allergic reaction 177 177
No Consequences Or Impact To Patient 171 171
Reaction 170 170
Inadequate Osseointegration 128 128
Loss of Range of Motion 124 124
No Known Impact Or Consequence To Patient 113 113
Ambulation Difficulties 98 98
Edema 89 89
Necrosis 89 89
Hematoma 81 81
Swelling 71 71
Weakness 69 69
Thrombosis 65 65
Distress 55 55
No Patient Involvement 50 50
Pulmonary Embolism 48 48
Fall 46 46
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 43 43
Failure of Implant 41 41
Cyst(s) 40 40
Adhesion(s) 38 38
Impaired Healing 32 32
Fatigue 31 31
Joint Disorder 30 30
Ossification 30 30
Scar Tissue 29 29
Synovitis 28 28
Death 26 26
No Clinical Signs, Symptoms or Conditions 25 25
Hemorrhage/Bleeding 24 24
Blood Loss 24 24
Toxicity 23 23
Hip Fracture 22 22
Insufficient Information 22 22
Anxiety 21 21
Local Reaction 19 19
Nerve Damage 17 17
Fever 17 17
Deformity/ Disfigurement 16 16
Depression 16 16
Muscular Rigidity 15 15
Post Operative Wound Infection 14 14
Dyspnea 13 13
Sepsis 11 11
Erosion 11 11
Wound Dehiscence 10 10
Aspiration/Inhalation 10 10
Bacterial Infection 10 10
Fibrosis 10 10
Joint Laxity 9 9
Foreign Body In Patient 9 9
Myocardial Infarction 9 9
Joint Swelling 9 9
Seroma 9 9
Scarring 8 8
Pocket Erosion 8 8
Stroke/CVA 8 8
Patient Problem/Medical Problem 8 8
Skin Irritation 8 8
Memory Loss/Impairment 8 8
Arthritis 7 7
Abscess 7 7
Osteopenia/ Osteoporosis 7 7
Cardiac Arrest 7 7
Headache 7 7
Sleep Dysfunction 6 6
Irritation 6 6
Neurological Deficit/Dysfunction 5 5
Rash 5 5
Renal Failure 5 5
Anemia 5 5
Hearing Impairment 5 5
Hypoesthesia 5 5
Nausea 5 5
Pneumonia 5 5
Tachycardia 5 5
Tinnitus 5 5
Unspecified Tissue Injury 5 5
Heart Failure 4 4
Itching Sensation 4 4
Fluid Discharge 4 4
Cognitive Changes 4 4
Calcium Deposits/Calcification 4 4
Neuropathy 4 4

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Apr-03-2020
2 Smith & Nephew, Inc. II Nov-03-2016
3 Zimmer Biomet, Inc. II Nov-22-2019
4 Zimmer Biomet, Inc. II Nov-07-2018
5 Zimmer Biomet, Inc. II Mar-14-2018
6 Zimmer Biomet, Inc. II Feb-15-2018
7 Zimmer Biomet, Inc. II Feb-22-2016
8 Zimmer Manufacturing B.V. II Mar-12-2016
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