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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
HERAEUS MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 1
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
ZIMMER GMBH
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2017 834 834
2018 1387 1387
2019 1534 1534
2020 1272 1272
2021 274 274

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1659 1659
Device Dislodged or Dislocated 1058 1058
Insufficient Information 1001 1001
Naturally Worn 521 521
Appropriate Term/Code Not Available 295 295
Fracture 193 193
Corroded 117 117
Loss of Osseointegration 109 109
Noise, Audible 88 88
Migration 84 84
Difficult to Insert 84 84
Material Erosion 74 74
Break 49 49
Loss of or Failure to Bond 44 44
Metal Shedding Debris 43 43
Migration or Expulsion of Device 41 41
Biocompatibility 40 40
Malposition of Device 36 36
Nonstandard Device 36 36
Degraded 36 36
Detachment of Device or Device Component 34 34
Loosening of Implant Not Related to Bone-Ingrowth 32 32
Osseointegration Problem 32 32
Loose or Intermittent Connection 29 29
Use of Device Problem 26 26
Unintended Movement 26 26
Unstable 21 21
Device Contaminated During Manufacture or Shipping 20 20
Delivered as Unsterile Product 19 19
Fitting Problem 17 17
Disassembly 14 14
Packaging Problem 13 13
Patient Device Interaction Problem 13 13
Device-Device Incompatibility 12 12
Material Disintegration 12 12
Difficult to Remove 11 11
Patient-Device Incompatibility 11 11
Positioning Failure 10 10
Separation Failure 9 9
Inadequacy of Device Shape and/or Size 7 7
Difficult To Position 7 7
Mechanical Problem 7 7
Positioning Problem 7 7
No Apparent Adverse Event 6 6
Detachment Of Device Component 6 6
Failure to Osseointegrate 6 6
Device Markings/Labelling Problem 5 5
Off-Label Use 5 5
Scratched Material 5 5
Material Deformation 5 5
Material Integrity Problem 4 4
Mechanical Jam 4 4
Contamination /Decontamination Problem 4 4
Connection Problem 4 4
Activation, Positioning or SeparationProblem 3 3
Defective Device 3 3
Device Damaged Prior to Use 3 3
Tear, Rip or Hole in Device Packaging 3 3
Material Separation 3 3
Bent 3 3
Device Expiration Issue 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Physical Resistance/Sticking 3 3
Separation Problem 2 2
Component Missing 2 2
Material Twisted/Bent 2 2
Difficult or Delayed Positioning 2 2
Failure To Adhere Or Bond 2 2
Device Appears to Trigger Rejection 2 2
Device Difficult to Setup or Prepare 2 2
Misconnection 2 2
Material Too Rigid or Stiff 2 2
Device Slipped 2 2
Dull, Blunt 2 2
Improper or Incorrect Procedure or Method 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
Installation-Related Problem 1 1
Deformation Due to Compressive Stress 1 1
Defective Component 1 1
Expiration Date Error 1 1
Failure to Disconnect 1 1
Shipping Damage or Problem 1 1
Misassembled 1 1
Incorrect Measurement 1 1
Excess Flow or Over-Infusion 1 1
Peeled/Delaminated 1 1
Pitted 1 1
Partial Blockage 1 1
Contamination 1 1
Crack 1 1
Material Discolored 1 1
Disconnection 1 1
Material Protrusion/Extrusion 1 1
Inaccurate Information 1 1
Activation Problem 1 1
Component Misassembled 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 2364 2367
Pain 1831 1832
Joint Dislocation 942 943
Unspecified Infection 737 738
Test Result 525 525
Foreign Body Reaction 461 461
Injury 432 432
No Information 379 379
Tissue Damage 304 304
Osteolysis 294 294
Not Applicable 293 293
Discomfort 240 240
Inflammation 204 204
Limited Mobility Of The Implanted Joint 195 195
Bone Fracture(s) 186 186
Hypersensitivity/Allergic reaction 177 177
No Consequences Or Impact To Patient 161 161
Reaction 157 157
Inadequate Osseointegration 129 129
Loss of Range of Motion 124 124
Ambulation Difficulties 97 97
Host-Tissue Reaction 92 92
Edema 88 88
No Known Impact Or Consequence To Patient 86 86
Hematoma 83 83
Necrosis 82 82
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 75 75
Failure of Implant 70 70
Thrombosis 65 65
No Clinical Signs, Symptoms or Conditions 62 62
Weakness 61 61
Swelling 60 60
Distress 52 52
Fall 52 52
No Patient Involvement 50 50
Insufficient Information 49 49
Pulmonary Embolism 48 48
Adhesion(s) 40 40
Cyst(s) 39 39
Ossification 34 34
Impaired Healing 33 33
Fatigue 31 31
Scar Tissue 29 29
Joint Disorder 26 26
Local Reaction 25 25
Death 25 25
Hemorrhage/Bleeding 24 24
Blood Loss 23 23
Anxiety 21 21
Synovitis 20 20
Toxicity 18 18
Hip Fracture 18 18
Nerve Damage 17 17
Fever 17 17
Joint Laxity 17 17
Deformity/ Disfigurement 16 16
Depression 16 16
Post Operative Wound Infection 14 14
Dyspnea 13 13
Bacterial Infection 12 12
Erosion 11 11
Muscular Rigidity 11 11
Sepsis 11 11
Metal Related Pathology 11 11
Fibrosis 10 10
Wound Dehiscence 10 10
Aspiration/Inhalation 10 10
Myocardial Infarction 9 9
Seroma 9 9
Osteopenia/ Osteoporosis 9 9
Patient Problem/Medical Problem 8 8
Pocket Erosion 8 8
Memory Loss/Impairment 8 8
Stroke/CVA 8 8
Cardiac Arrest 7 7
Abscess 7 7
Headache 7 7
Skin Irritation 7 7
Foreign Body In Patient 7 7
Sleep Dysfunction 7 7
Unspecified Tissue Injury 7 7
Swelling/ Edema 7 7
Scarring 6 6
Arthritis 6 6
Calcium Deposits/Calcification 5 5
Anemia 5 5
Hearing Impairment 5 5
Neurological Deficit/Dysfunction 5 5
Nausea 5 5
Rash 5 5
Renal Failure 5 5
Tachycardia 5 5
Tinnitus 5 5
Muscle/Tendon Damage 5 5
Physical Asymmetry 4 4
Heart Failure 4 4
Cognitive Changes 4 4
Fluid Discharge 4 4
Hypoesthesia 4 4
Pneumonia 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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