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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
G21, S.R.L.
  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 1

MDR Year MDR Reports MDR Events
2018 1387 1387
2019 1534 1534
2020 1272 1272
2021 278 278
2022 210 210
2023 71 71

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1723 1723
Device Dislodged or Dislocated 987 987
Insufficient Information 650 650
Naturally Worn 486 486
Fracture 193 193
Appropriate Term/Code Not Available 168 168
Loss of Osseointegration 96 96
Migration 88 88
Corroded 86 86
Difficult to Insert 85 85
Noise, Audible 78 78
Material Erosion 67 67
Loss of or Failure to Bond 43 43
Break 41 41
Detachment of Device or Device Component 40 40
Biocompatibility 40 40
Loosening of Implant Not Related to Bone-Ingrowth 40 40
Nonstandard Device 34 34
Degraded 33 33
Osseointegration Problem 33 33
Malposition of Device 31 31
Migration or Expulsion of Device 29 29
Unintended Movement 26 26
Loose or Intermittent Connection 25 25
Use of Device Problem 24 24
Device Contaminated During Manufacture or Shipping 21 21
Unstable 20 20
Delivered as Unsterile Product 20 20
Patient Device Interaction Problem 17 17
Fitting Problem 16 16
Packaging Problem 14 14
Metal Shedding Debris 12 12
Difficult to Remove 11 11
Positioning Failure 11 11
Separation Failure 10 10
Device-Device Incompatibility 10 10
Failure to Osseointegrate 9 9
Material Disintegration 9 9
Patient-Device Incompatibility 8 8
No Apparent Adverse Event 8 8
Positioning Problem 7 7
Inadequacy of Device Shape and/or Size 7 7
Disassembly 7 7
Off-Label Use 7 7
Mechanical Problem 6 6
Tear, Rip or Hole in Device Packaging 5 5
Contamination /Decontamination Problem 5 5
Scratched Material 5 5
Mechanical Jam 4 4
Material Deformation 4 4
Difficult To Position 4 4
Device Appears to Trigger Rejection 3 3
Defective Device 3 3
Activation, Positioning or Separation Problem 3 3
Device Markings/Labelling Problem 3 3
Expiration Date Error 3 3
Material Separation 3 3
Material Integrity Problem 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Physical Resistance/Sticking 3 3
Separation Problem 2 2
Material Twisted/Bent 2 2
Improper or Incorrect Procedure or Method 2 2
Dull, Blunt 2 2
Device Damaged Prior to Use 2 2
Device Contamination with Chemical or Other Material 2 2
Human-Device Interface Problem 2 2
Connection Problem 2 2
Deformation Due to Compressive Stress 2 2
Material Too Rigid or Stiff 2 2
Contamination 2 2
Device Expiration Issue 2 2
Difficult or Delayed Positioning 2 2
Crack 2 2
Detachment Of Device Component 1 1
Failure To Adhere Or Bond 1 1
Bent 1 1
Material Discolored 1 1
Disconnection 1 1
Device Difficult to Setup or Prepare 1 1
Misassembled 1 1
Peeled/Delaminated 1 1
Pitted 1 1
Incorrect Measurement 1 1
Compatibility Problem 1 1
Installation-Related Problem 1 1
Device Packaging Compromised 1 1
Component Missing 1 1
Incomplete or Missing Packaging 1 1
Failure to Disconnect 1 1
Shipping Damage or Problem 1 1
No Fail-Safe Mechanism 1 1
Inaccurate Information 1 1
Unclear Information 1 1
Activation Problem 1 1
Component Misassembled 1 1
Material Split, Cut or Torn 1 1
Misassembly by Users 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 2257 2260
Pain 1542 1543
Joint Dislocation 913 914
Unspecified Infection 711 712
Test Result 521 521
Foreign Body Reaction 401 401
Injury 387 387
Not Applicable 288 288
Tissue Damage 280 280
Osteolysis 278 278
Discomfort 197 197
No Information 192 192
Bone Fracture(s) 192 192
Limited Mobility Of The Implanted Joint 183 183
Inflammation 182 182
Hypersensitivity/Allergic reaction 172 172
No Consequences Or Impact To Patient 147 147
Inadequate Osseointegration 140 140
Reaction 128 128
Loss of Range of Motion 122 122
No Clinical Signs, Symptoms or Conditions 101 101
Failure of Implant 88 88
Hematoma 88 88
Ambulation Difficulties 81 81
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 81 81
Insufficient Information 79 79
Necrosis 79 79
Edema 77 77
No Known Impact Or Consequence To Patient 72 72
Thrombosis 65 65
Fall 65 65
Distress 59 59
Weakness 55 55
Pulmonary Embolism 50 50
Swelling 49 49
No Patient Involvement 47 47
Host-Tissue Reaction 45 45
Adhesion(s) 44 44
Fatigue 39 39
Metal Related Pathology 39 39
Joint Laxity 36 36
Ossification 34 34
Impaired Healing 34 34
Scar Tissue 33 33
Cyst(s) 29 29
Hemorrhage/Bleeding 27 27
Joint Disorder 23 23
Hip Fracture 23 23
Anxiety 22 22
Blood Loss 22 22
Local Reaction 21 21
Nerve Damage 20 20
Death 20 20
Unspecified Tissue Injury 19 19
Swelling/ Edema 17 17
Bacterial Infection 17 17
Deformity/ Disfigurement 17 17
Fever 16 16
Depression 15 15
Synovitis 14 14
Osteopenia/ Osteoporosis 14 14
Toxicity 12 12
Wound Dehiscence 12 12
Muscular Rigidity 11 11
Post Operative Wound Infection 11 11
Sepsis 10 10
Erosion 10 10
Dyspnea 10 10
Myocardial Infarction 9 9
Pocket Erosion 9 9
Physical Asymmetry 9 9
Fibrosis 9 9
Muscle/Tendon Damage 8 8
Stroke/CVA 8 8
Seroma 8 8
Patient Problem/Medical Problem 8 8
Foreign Body In Patient 7 7
Skin Irritation 7 7
Tinnitus 6 6
Fluid Discharge 6 6
Sleep Dysfunction 6 6
Calcium Deposits/Calcification 6 6
Cardiac Arrest 6 6
Memory Loss/Impairment 6 6
Hearing Impairment 6 6
Headache 5 5
Nausea 5 5
Rash 5 5
Renal Failure 5 5
Scarring 5 5
Neurological Deficit/Dysfunction 5 5
Abscess 5 5
Anemia 5 5
Tachycardia 5 5
Arthralgia 5 5
Implant Pain 5 5
Hypoesthesia 4 4
Heart Failure 4 4
Vertigo 4 4
Cognitive Changes 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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