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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, hip, constrained, cemented or uncemented, metal/polymer
Product CodeKWZ
Regulation Number 888.3310
Device Class 2


Premarket Reviews
ManufacturerDecision
DEPUY IRELAND UC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 533 533
2020 288 288
2021 216 216
2022 158 158
2023 165 165
2024 79 79

Device Problems MDRs with this Device Problem Events in those MDRs
Device Dislodged or Dislocated 616 616
Adverse Event Without Identified Device or Use Problem 315 315
Naturally Worn 131 131
Fracture 121 121
Device Contaminated During Manufacture or Shipping 68 68
Insufficient Information 55 55
Appropriate Term/Code Not Available 48 48
Detachment of Device or Device Component 44 44
Difficult to Insert 29 29
Unstable 24 24
Break 22 22
Noise, Audible 18 18
Packaging Problem 15 15
Positioning Failure 12 12
Off-Label Use 11 11
Loose or Intermittent Connection 11 11
Material Deformation 11 11
Device-Device Incompatibility 11 11
Loosening of Implant Not Related to Bone-Ingrowth 11 11
Nonstandard Device 10 10
Scratched Material 9 9
Unintended Movement 8 8
Migration 7 7
Separation Failure 7 7
Malposition of Device 7 7
Tear, Rip or Hole in Device Packaging 6 6
Material Erosion 6 6
Loss of or Failure to Bond 6 6
Difficult to Remove 5 5
Loss of Osseointegration 5 5
Biocompatibility 5 5
Use of Device Problem 5 5
Inadequacy of Device Shape and/or Size 5 5
Fitting Problem 5 5
Mechanical Problem 4 4
Patient Device Interaction Problem 4 4
Connection Problem 3 3
Material Twisted/Bent 3 3
Device Difficult to Setup or Prepare 3 3
Shipping Damage or Problem 3 3
Improper or Incorrect Procedure or Method 3 3
Failure to Osseointegrate 2 2
Deformation Due to Compressive Stress 2 2
Contamination /Decontamination Problem 2 2
Defective Device 2 2
Material Separation 2 2
Degraded 2 2
Corroded 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Osseointegration Problem 2 2
Component Missing 2 2
Difficult to Open or Close 2 2
Illegible Information 2 2
Physical Resistance/Sticking 1 1
Difficult or Delayed Separation 1 1
No Apparent Adverse Event 1 1
Therapeutic or Diagnostic Output Failure 1 1
Excessive Cooling 1 1
Device Contamination with Chemical or Other Material 1 1
Device Damaged by Another Device 1 1
Positioning Problem 1 1
Mechanical Jam 1 1
Crack 1 1
Delivered as Unsterile Product 1 1
Material Disintegration 1 1
Problem with Sterilization 1 1
Defective Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Joint Dislocation 534 534
No Code Available 431 431
Pain 206 206
Unspecified Infection 146 146
Injury 97 97
Insufficient Information 85 85
No Clinical Signs, Symptoms or Conditions 81 81
Osteolysis 57 57
No Patient Involvement 56 56
Foreign Body Reaction 55 55
Joint Laxity 49 49
No Information 43 43
Failure of Implant 41 41
Fall 39 39
No Known Impact Or Consequence To Patient 38 38
No Consequences Or Impact To Patient 33 33
Tissue Damage 32 32
Test Result 32 32
Ambulation Difficulties 30 30
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 28 28
Limited Mobility Of The Implanted Joint 26 26
Loss of Range of Motion 25 25
Hypersensitivity/Allergic reaction 23 23
Bone Fracture(s) 20 20
Discomfort 17 17
Not Applicable 17 17
Hematoma 14 14
Ossification 11 11
Scar Tissue 11 11
Inflammation 11 11
Osteopenia/ Osteoporosis 11 11
Adhesion(s) 10 10
Edema 10 10
Thrombosis 9 9
Inadequate Osseointegration 9 9
Unspecified Tissue Injury 8 8
Metal Related Pathology 8 8
Joint Disorder 7 7
Swelling 7 7
Weakness 7 7
Necrosis 7 7
Pulmonary Embolism 7 7
Cyst(s) 6 6
Fatigue 6 6
Impaired Healing 6 6
Reaction 6 6
Swelling/ Edema 6 6
Hemorrhage/Bleeding 5 5
Cardiac Arrest 4 4
Erosion 4 4
Wound Dehiscence 4 4
Unspecified Musculoskeletal problem 4 4
Deformity/ Disfigurement 4 4
Patient Problem/Medical Problem 3 3
Muscle/Tendon Damage 3 3
Host-Tissue Reaction 3 3
Rheumatoid Arthritis 3 3
Death 3 3
Infarction, Cerebral 3 3
Hip Fracture 3 3
Anxiety 3 3
Distress 3 3
Synovitis 2 2
Arthralgia 2 2
Nerve Damage 2 2
Scarring 2 2
Seroma 2 2
Nausea 2 2
Respiratory Distress 2 2
Physical Asymmetry 2 2
Thrombosis/Thrombus 2 2
Limb Fracture 2 2
Subluxation 1 1
Fibrosis 1 1
Blood Loss 1 1
Fluid Discharge 1 1
Unequal Limb Length 1 1
Implant Pain 1 1
Local Reaction 1 1
Renal Failure 1 1
Skin Discoloration 1 1
Pneumonia 1 1
Pocket Erosion 1 1
Itching Sensation 1 1
Muscle Weakness 1 1
Muscular Rigidity 1 1
Hypoesthesia 1 1
Numbness 1 1
Thrombus 1 1
Infiltration into Tissue 1 1
High Blood Pressure/ Hypertension 1 1
Erythema 1 1
Headache 1 1
Hearing Impairment 1 1
Stroke/CVA 1 1
Aspiration/Inhalation 1 1
Atrial Fibrillation 1 1
Bruise/Contusion 1 1
Calcium Deposits/Calcification 1 1
Abscess 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Encore Medical, Lp II Apr-10-2019
2 Exactech, Inc. II Jan-18-2024
3 Exactech, Inc. II Sep-09-2022
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