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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
DEPUY IRELAND UC
  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
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
2019 1530 1530
2020 1260 1260
2021 276 276
2022 208 208
2023 177 177
2024 98 98

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1556 1556
Device Dislodged or Dislocated 807 807
Naturally Worn 397 397
Fracture 179 179
Insufficient Information 105 105
Difficult to Insert 86 86
Loss of Osseointegration 80 80
Migration 76 76
Noise, Audible 62 62
Appropriate Term/Code Not Available 60 60
Corroded 59 59
Loosening of Implant Not Related to Bone-Ingrowth 43 43
Material Erosion 42 42
Loss of or Failure to Bond 41 41
Biocompatibility 35 35
Detachment of Device or Device Component 34 34
Nonstandard Device 32 32
Degraded 31 31
Osseointegration Problem 28 28
Break 25 25
Use of Device Problem 25 25
Unintended Movement 23 23
Malposition of Device 22 22
Device Contaminated During Manufacture or Shipping 21 21
Delivered as Unsterile Product 20 20
Patient Device Interaction Problem 19 19
Unstable 14 14
Positioning Failure 12 12
Packaging Problem 11 11
Device-Device Incompatibility 10 10
Separation Failure 8 8
Off-Label Use 8 8
No Apparent Adverse Event 8 8
Difficult to Remove 7 7
Failure to Osseointegrate 7 7
Fitting Problem 7 7
Mechanical Problem 7 7
Loose or Intermittent Connection 6 6
Inadequacy of Device Shape and/or Size 5 5
Patient-Device Incompatibility 5 5
Mechanical Jam 4 4
Positioning Problem 4 4
Scratched Material 4 4
Device Damaged Prior to Use 4 4
Crack 4 4
Expiration Date Error 3 3
Tear, Rip or Hole in Device Packaging 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Contamination /Decontamination Problem 3 3
Activation, Positioning or Separation Problem 3 3
Physical Resistance/Sticking 3 3
Device Markings/Labelling Problem 2 2
Device Contamination with Chemical or Other Material 2 2
Deformation Due to Compressive Stress 2 2
Material Integrity Problem 2 2
Material Twisted/Bent 2 2
Material Separation 2 2
Material Disintegration 2 2
Difficult or Delayed Positioning 2 2
Migration or Expulsion of Device 2 2
Misassembled 1 1
Pitted 1 1
Incorrect Measurement 1 1
Contamination 1 1
Shipping Damage or Problem 1 1
Material Too Rigid or Stiff 1 1
Device Appears to Trigger Rejection 1 1
Dull, Blunt 1 1
Incomplete or Missing Packaging 1 1
Solder Joint Fracture 1 1
Material Deformation 1 1
No Fail-Safe Mechanism 1 1
Misassembly by Users 1 1
Connection Problem 1 1
Defective Device 1 1
Human-Device Interface Problem 1 1
Compatibility Problem 1 1
Installation-Related Problem 1 1
Activation Problem 1 1
Inaccurate Information 1 1
Unclear Information 1 1
Component Misassembled 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 1995 1998
Pain 1088 1089
Joint Dislocation 724 725
Unspecified Infection 615 616
Test Result 421 421
Foreign Body Reaction 352 352
Osteolysis 218 218
Injury 169 169
Bone Fracture(s) 160 160
Tissue Damage 156 156
Hypersensitivity/Allergic reaction 153 153
No Clinical Signs, Symptoms or Conditions 128 128
Limited Mobility Of The Implanted Joint 124 124
Inadequate Osseointegration 112 112
Insufficient Information 109 109
Discomfort 109 109
Failure of Implant 106 106
Loss of Range of Motion 90 90
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 77 77
No Consequences Or Impact To Patient 76 76
Inflammation 74 74
No Information 68 68
Edema 67 67
Hematoma 63 63
Fall 60 60
Necrosis 60 60
Not Applicable 60 60
Thrombosis 60 60
Joint Laxity 50 50
No Known Impact Or Consequence To Patient 47 47
Pulmonary Embolism 45 45
No Patient Involvement 43 43
Ambulation Difficulties 43 43
Adhesion(s) 37 37
Metal Related Pathology 34 34
Weakness 32 32
Ossification 30 30
Fatigue 27 27
Scar Tissue 27 27
Cyst(s) 26 26
Hemorrhage/Bleeding 25 25
Reaction 21 21
Swelling 20 20
Nerve Damage 19 19
Hip Fracture 17 17
Unspecified Tissue Injury 16 16
Joint Disorder 15 15
Impaired Healing 15 15
Anxiety 15 15
Local Reaction 15 15
Fever 14 14
Death 14 14
Osteopenia/ Osteoporosis 14 14
Wound Dehiscence 13 13
Swelling/ Edema 12 12
Depression 11 11
Host-Tissue Reaction 11 11
Dyspnea 10 10
Synovitis 10 10
Distress 10 10
Muscle/Tendon Damage 10 10
Deformity/ Disfigurement 9 9
Sepsis 9 9
Stroke/CVA 8 8
Post Operative Wound Infection 8 8
Implant Pain 8 8
Physical Asymmetry 8 8
Patient Problem/Medical Problem 8 8
Fibrosis 8 8
Arthralgia 7 7
Pocket Erosion 7 7
Myocardial Infarction 7 7
Seroma 6 6
Hearing Impairment 6 6
Skin Irritation 6 6
Toxicity 6 6
Sleep Dysfunction 6 6
Blood Loss 5 5
Fluid Discharge 5 5
Tinnitus 5 5
Erosion 5 5
Calcium Deposits/Calcification 5 5
Tachycardia 5 5
Muscular Rigidity 5 5
Neurological Deficit/Dysfunction 5 5
Memory Loss/Impairment 4 4
Renal Failure 4 4
Rash 4 4
Cardiac Arrest 4 4
Abscess 4 4
Foreign Body In Patient 4 4
Thromboembolism 3 3
Limb Fracture 3 3
Thrombosis/Thrombus 3 3
Burning Sensation 3 3
Heart Failure 3 3
Hypoesthesia 3 3
Non-union Bone Fracture 3 3
Numbness 3 3
Arthritis 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Apr-03-2020
2 Zimmer Biomet, Inc. II Nov-22-2019
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