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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
Product CodeKWY
Regulation Number 888.3390
Device Class 2


Premarket Reviews
ManufacturerDecision
CORIN USA LIMITED
  SUBSTANTIALLY EQUIVALENT 1
HERAEUS MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 2
IMPLANTCAST, GMBH
  SUBSTANTIALLY EQUIVALENT 1
KYOCERA MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
ONKOS SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SIGNATURE ORTHOPAEDICS PTY LTD.
  SUBSTANTIALLY EQUIVALENT 1
SURGTECH, INC.,
  SUBSTANTIALLY EQUIVALENT 1
THEKEN COMPANIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
WALDEMAR LINK GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER GMBH
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2017 834 834
2018 1387 1387
2019 1534 1534
2020 1272 1272
2021 278 278
2022 189 189

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1743 1743
Device Dislodged or Dislocated 1102 1102
Insufficient Information 1004 1004
Naturally Worn 525 525
Appropriate Term/Code Not Available 304 304
Fracture 203 203
Corroded 117 117
Loss of Osseointegration 117 117
Difficult to Insert 94 94
Noise, Audible 89 89
Migration 88 88
Material Erosion 78 78
Break 52 52
Loss of or Failure to Bond 45 45
Metal Shedding Debris 43 43
Migration or Expulsion of Device 41 41
Biocompatibility 40 40
Detachment of Device or Device Component 39 39
Malposition of Device 37 37
Nonstandard Device 36 36
Degraded 36 36
Loosening of Implant Not Related to Bone-Ingrowth 36 36
Osseointegration Problem 34 34
Loose or Intermittent Connection 29 29
Use of Device Problem 28 28
Unintended Movement 26 26
Unstable 22 22
Device Contaminated During Manufacture or Shipping 21 21
Delivered as Unsterile Product 20 20
Fitting Problem 17 17
Patient Device Interaction Problem 16 16
Packaging Problem 14 14
Disassembly 14 14
Material Disintegration 12 12
Device-Device Incompatibility 12 12
Difficult to Remove 11 11
Patient-Device Incompatibility 11 11
Positioning Failure 10 10
Separation Failure 9 9
Mechanical Problem 8 8
No Apparent Adverse Event 8 8
Positioning Problem 7 7
Difficult To Position 7 7
Off-Label Use 7 7
Inadequacy of Device Shape and/or Size 7 7
Failure to Osseointegrate 7 7
Detachment Of Device Component 6 6
Tear, Rip or Hole in Device Packaging 5 5
Device Markings/Labelling Problem 5 5
Scratched Material 5 5
Material Deformation 5 5
Material Integrity Problem 4 4
Contamination /Decontamination Problem 4 4
Connection Problem 4 4
Mechanical Jam 4 4
Physical Resistance/Sticking 3 3
Activation, Positioning or Separation Problem 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Defective Device 3 3
Device Damaged Prior to Use 3 3
Material Separation 3 3
Bent 3 3
Device Expiration Issue 3 3
Device Appears to Trigger Rejection 3 3
Device Difficult to Setup or Prepare 2 2
Misconnection 2 2
Difficult or Delayed Positioning 2 2
Failure To Adhere Or Bond 2 2
Material Too Rigid or Stiff 2 2
Device Slipped 2 2
Improper or Incorrect Procedure or Method 2 2
Dull, Blunt 2 2
Component Missing 2 2
Expiration Date Error 2 2
Device Damaged by Another Device 2 2
Device Packaging Compromised 2 2
Device Contamination with Chemical or Other Material 2 2
Human-Device Interface Problem 2 2
Compatibility Problem 2 2
Material Twisted/Bent 2 2
Separation Problem 2 2
Inaccurate Information 1 1
Activation Problem 1 1
Component Misassembled 1 1
Material Split, Cut or Torn 1 1
Material Protrusion/Extrusion 1 1
Misassembly by Users 1 1
No Fail-Safe Mechanism 1 1
Installation-Related Problem 1 1
Failure to Disconnect 1 1
Deformation Due to Compressive Stress 1 1
Incomplete or Missing Packaging 1 1
Defective Component 1 1
Shipping Damage or Problem 1 1
Partial Blockage 1 1
Contamination 1 1
Crack 1 1
Material Discolored 1 1
Disconnection 1 1
Misassembled 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 2364 2367
Pain 1862 1863
Joint Dislocation 987 988
Unspecified Infection 780 781
Test Result 525 525
Foreign Body Reaction 472 472
Injury 432 432
No Information 379 379
Tissue Damage 304 304
Osteolysis 301 301
Not Applicable 293 293
Discomfort 243 243
Inflammation 208 208
Bone Fracture(s) 203 203
Limited Mobility Of The Implanted Joint 195 195
Hypersensitivity/Allergic reaction 180 180
No Consequences Or Impact To Patient 161 161
Reaction 157 157
Inadequate Osseointegration 144 144
Loss of Range of Motion 134 134
Ambulation Difficulties 105 105
Host-Tissue Reaction 92 92
Failure of Implant 90 90
No Clinical Signs, Symptoms or Conditions 89 89
Necrosis 88 88
Hematoma 88 88
Edema 88 88
No Known Impact Or Consequence To Patient 86 86
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 83 83
Thrombosis 65 65
Distress 62 62
Weakness 61 61
Fall 61 61
Insufficient Information 61 61
Swelling 60 60
No Patient Involvement 50 50
Pulmonary Embolism 50 50
Adhesion(s) 45 45
Cyst(s) 40 40
Fatigue 37 37
Ossification 35 35
Scar Tissue 35 35
Impaired Healing 34 34
Metal Related Pathology 32 32
Joint Laxity 30 30
Joint Disorder 26 26
Hemorrhage/Bleeding 26 26
Death 25 25
Local Reaction 25 25
Anxiety 24 24
Blood Loss 23 23
Hip Fracture 22 22
Nerve Damage 21 21
Synovitis 20 20
Toxicity 18 18
Deformity/ Disfigurement 18 18
Unspecified Tissue Injury 18 18
Depression 17 17
Fever 17 17
Swelling/ Edema 16 16
Post Operative Wound Infection 14 14
Osteopenia/ Osteoporosis 14 14
Dyspnea 13 13
Wound Dehiscence 12 12
Bacterial Infection 12 12
Muscular Rigidity 12 12
Erosion 11 11
Sepsis 11 11
Aspiration/Inhalation 10 10
Fibrosis 10 10
Physical Asymmetry 9 9
Myocardial Infarction 9 9
Pocket Erosion 9 9
Seroma 9 9
Patient Problem/Medical Problem 8 8
Memory Loss/Impairment 8 8
Stroke/CVA 8 8
Muscle/Tendon Damage 8 8
Cardiac Arrest 7 7
Abscess 7 7
Headache 7 7
Foreign Body In Patient 7 7
Sleep Dysfunction 7 7
Skin Irritation 7 7
Scarring 6 6
Arthritis 6 6
Calcium Deposits/Calcification 6 6
Anemia 5 5
Hearing Impairment 5 5
Neurological Deficit/Dysfunction 5 5
Nausea 5 5
Tachycardia 5 5
Tinnitus 5 5
Renal Failure 5 5
Rash 5 5
Heart Failure 4 4
Cognitive Changes 4 4
Fluid Discharge 4 4
Numbness 4 4
Hypoesthesia 4 4

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Apr-03-2020
2 Zimmer Biomet, Inc. II Nov-22-2019
3 Zimmer Biomet, Inc. II Nov-07-2018
4 Zimmer Biomet, Inc. II Mar-14-2018
5 Zimmer Biomet, Inc. II Feb-15-2018
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