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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 68 68

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1545 1545
Device Dislodged or Dislocated 797 797
Naturally Worn 397 397
Fracture 176 176
Insufficient Information 105 105
Difficult to Insert 85 85
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 34 34
Detachment of Device or Device Component 33 33
Nonstandard Device 32 32
Degraded 30 30
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 17 17
Unstable 14 14
Packaging Problem 11 11
Positioning Failure 11 11
Device-Device Incompatibility 10 10
Separation Failure 8 8
Off-Label Use 8 8
Difficult to Remove 7 7
Failure to Osseointegrate 7 7
Fitting Problem 7 7
Mechanical Problem 7 7
No Apparent Adverse Event 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 1082 1083
Joint Dislocation 716 717
Unspecified Infection 611 612
Test Result 421 421
Foreign Body Reaction 351 351
Osteolysis 217 217
Injury 169 169
Bone Fracture(s) 159 159
Tissue Damage 156 156
Hypersensitivity/Allergic reaction 153 153
No Clinical Signs, Symptoms or Conditions 126 126
Limited Mobility Of The Implanted Joint 124 124
Inadequate Osseointegration 111 111
Discomfort 109 109
Insufficient Information 105 105
Failure of Implant 101 101
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 61 61
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 42 42
Adhesion(s) 37 37
Weakness 32 32
Metal Related Pathology 30 30
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
Impaired Healing 15 15
Joint Disorder 15 15
Anxiety 15 15
Local Reaction 15 15
Fever 14 14
Death 14 14
Osteopenia/ Osteoporosis 14 14
Swelling/ Edema 12 12
Depression 11 11
Wound Dehiscence 11 11
Host-Tissue Reaction 11 11
Dyspnea 10 10
Distress 10 10
Synovitis 9 9
Deformity/ Disfigurement 9 9
Sepsis 9 9
Stroke/CVA 8 8
Post Operative Wound Infection 8 8
Physical Asymmetry 8 8
Patient Problem/Medical Problem 8 8
Fibrosis 8 8
Implant Pain 7 7
Muscle/Tendon Damage 7 7
Arthralgia 7 7
Pocket Erosion 7 7
Myocardial Infarction 7 7
Skin Irritation 6 6
Hearing Impairment 6 6
Toxicity 6 6
Sleep Dysfunction 6 6
Tachycardia 5 5
Tinnitus 5 5
Fluid Discharge 5 5
Blood Loss 5 5
Erosion 5 5
Calcium Deposits/Calcification 5 5
Seroma 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
Thrombosis/Thrombus 3 3
Limb Fracture 3 3
Burning Sensation 3 3
Heart Failure 3 3
Numbness 3 3
Hypoesthesia 3 3
Non-union Bone Fracture 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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