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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
TOTAL JOINT ORTHOPEDICS
  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
2015 1214 1214
2016 884 884
2017 834 834
2018 1397 1397
2019 1536 1536
2020 1029 1029

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 2049 2049
Adverse Event Without Identified Device or Use Problem 1535 1535
Device Dislodged or Dislocated 1240 1240
Naturally Worn 594 594
Appropriate Term/Code Not Available 588 588
Fracture 195 195
Loss of Osseointegration 187 187
Corroded 155 155
Noise, Audible 133 133
Metal Shedding Debris 88 88
Material Erosion 85 85
Break 65 65
Difficult to Insert 64 64
Migration 61 61
Malposition of Device 59 59
Migration or Expulsion of Device 59 59
Nonstandard Device 58 58
Loss of or Failure to Bond 50 50
Loose or Intermittent Connection 50 50
Disassembly 40 40
Biocompatibility 39 39
Degraded 34 34
Device Contamination with Chemical or Other Material 33 33
Unstable 28 28
Loosening of Implant Not Related to Bone-Ingrowth 25 25
Detachment of Device or Device Component 24 24
Osseointegration Problem 24 24
Unintended Movement 23 23
Use of Device Problem 23 23
Material Disintegration 22 22
Delivered as Unsterile Product 19 19
Fitting Problem 19 19
Device Contaminated During Manufacture or Shipping 17 17
Device Slipped 16 16
Packaging Problem 16 16
Detachment Of Device Component 15 15
Difficult to Remove 14 14
Patient-Device Incompatibility 12 12
Mechanical Problem 11 11
Separation Failure 10 10
Inadequacy of Device Shape and/or Size 10 10
Device Operates Differently Than Expected 9 9
No Apparent Adverse Event 8 8
Difficult To Position 8 8
Compatibility Problem 8 8
Device-Device Incompatibility 8 8
Material Integrity Problem 8 8
Positioning Problem 7 7
Scratched Material 6 6
Device Damaged Prior to Use 6 6
Improper or Incorrect Procedure or Method 6 6
Failure to Osseointegrate 6 6
Off-Label Use 6 6
Material Separation 5 5
Bent 5 5
Device Markings/Labelling Problem 5 5
Material Deformation 5 5
Contamination /Decontamination Problem 4 4
Connection Problem 4 4
Device Difficult to Setup or Prepare 4 4
Patient Device Interaction Problem 4 4
Device Packaging Compromised 3 3
Defective Device 3 3
Device Expiration Issue 3 3
Component Missing 3 3
Crack 3 3
Tear, Rip or Hole in Device Packaging 3 3
Failure To Adhere Or Bond 3 3
Difficult or Delayed Positioning 2 2
Material Discolored 2 2
Misassembled 2 2
Misconnection 2 2
Dull, Blunt 2 2
Device Disinfection Or Sterilization Issue 2 2
Physical Resistance/Sticking 2 2
Positioning Failure 2 2
Heads 2 2
Shelf Life Exceeded 2 2
Device Damaged by Another Device 2 2
Material Twisted/Bent 2 2
Mechanical Jam 2 2
Human-Device Interface Problem 2 2
Separation Problem 2 2
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
Shipping Damage or Problem 1 1
Material Too Rigid or Stiff 1 1
Device Issue 1 1
Expiration Date Error 1 1
Device Abrasion From Instrument Or Another Object 1 1
Pitted 1 1
Plate 1 1
Ring 1 1
Screw 1 1
Cup 1 1
Cutter/Blade 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 2762 2765
Pain 2715 2716
No Information 956 956
Joint Dislocation 888 889
Unspecified Infection 821 822
Foreign Body Reaction 578 578
Test Result 556 556
Injury 475 475
Discomfort 386 386
Osteolysis 343 343
Tissue Damage 326 326
Not Applicable 311 311
Host-Tissue Reaction 289 289
Inflammation 257 257
Limited Mobility Of The Implanted Joint 240 240
Bone Fracture(s) 199 199
Reaction 180 180
No Consequences Or Impact To Patient 180 180
Hypersensitivity/Allergic reaction 172 172
Loss of Range of Motion 131 131
No Known Impact Or Consequence To Patient 128 128
Inadequate Osseointegration 114 114
Edema 92 92
Ambulation Difficulties 91 91
Necrosis 87 87
Hematoma 79 79
Swelling 75 75
Weakness 70 70
Thrombosis 63 63
Distress 55 55
No Patient Involvement 50 50
Fall 50 50
Pulmonary Embolism 44 44
Toxicity 44 44
Cyst(s) 40 40
Failure of Implant 37 37
Adhesion(s) 36 36
Synovitis 33 33
Impaired Healing 32 32
Fatigue 32 32
Joint Disorder 30 30
Scar Tissue 29 29
Ossification 29 29
Death 27 27
Hemorrhage/Bleeding 24 24
Blood Loss 24 24
Hip Fracture 22 22
Anxiety 21 21
Fever 17 17
Deformity/ Disfigurement 16 16
Depression 16 16
Local Reaction 16 16
Muscular Rigidity 16 16
Joint Swelling 14 14
Nerve Damage 13 13
Post Operative Wound Infection 13 13
Erosion 11 11
Wound Dehiscence 10 10
Aspiration/Inhalation 10 10
Sepsis 10 10
Fibrosis 10 10
Bacterial Infection 10 10
Myocardial Infarction 9 9
Seroma 9 9
Foreign Body In Patient 9 9
Arthritis 9 9
Dyspnea 9 9
Irritation 9 9
Memory Loss/Impairment 8 8
Rash 8 8
Muscle Weakness 8 8
Skin Irritation 8 8
Patient Problem/Medical Problem 8 8
Scarring 8 8
Pocket Erosion 8 8
Complaint, Ill-Defined 8 8
Headache 8 8
Cardiac Arrest 8 8
Stroke/CVA 7 7
Abscess 7 7
Neurological Deficit/Dysfunction 6 6
Vertigo 6 6
Osteopenia/ Osteoporosis 6 6
Fluid Discharge 6 6
Nausea 6 6
Pneumonia 5 5
Tachycardia 5 5
Tinnitus 5 5
Cognitive Changes 5 5
Hypoesthesia 5 5
Renal Failure 5 5
Anemia 5 5
Hearing Impairment 5 5
Neuropathy 4 4
Muscle Spasm(s) 4 4
Erythema 4 4
Heart Failure 4 4
Itching Sensation 4 4
Atrial Fibrillation 3 3
Granuloma 3 3

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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