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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
ENCORE MEDICAL, L.P.
  SUBSTANTIALLY EQUIVALENT 2
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 4
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 278 278
2015 634 634
2016 1181 1181
2017 478 478
2018 282 282
2019 533 533
2020 288 288
2021 216 216
2022 158 158
2023 164 164
2024 31 31

Device Problems MDRs with this Device Problem Events in those MDRs
Device Dislodged or Dislocated 1467 1467
Insufficient Information 1119 1119
Adverse Event Without Identified Device or Use Problem 371 371
Fracture 236 236
Naturally Worn 203 203
Appropriate Term/Code Not Available 185 185
Failure To Adhere Or Bond 149 149
Migration or Expulsion of Device 114 114
Corroded 99 99
Break 98 98
Unstable 82 82
Device Contaminated During Manufacture or Shipping 68 68
Detachment of Device or Device Component 50 50
Difficult to Insert 46 46
Disassembly 45 45
Malposition of Device 43 43
Loose or Intermittent Connection 28 28
Noise, Audible 28 28
Mechanical Problem 23 23
Device Operates Differently Than Expected 21 21
Device Slipped 21 21
Material Erosion 20 20
Material Deformation 20 20
Scratched Material 19 19
Material Separation 19 19
Detachment Of Device Component 19 19
Fitting Problem 18 18
Loss of Osseointegration 18 18
Nonstandard Device 15 15
Packaging Problem 15 15
Loss of or Failure to Bond 13 13
Positioning Failure 12 12
Off-Label Use 12 12
Positioning Problem 11 11
Material Integrity Problem 11 11
Loosening of Implant Not Related to Bone-Ingrowth 11 11
Difficult to Remove 10 10
Improper or Incorrect Procedure or Method 10 10
Separation Failure 10 10
Tear, Rip or Hole in Device Packaging 10 10
Use of Device Problem 9 9
Metal Shedding Debris 9 9
Migration 9 9
Unintended Movement 9 9
Compatibility Problem 8 8
Device-Device Incompatibility 8 8
Biocompatibility 7 7
Crack 7 7
Failure to Osseointegrate 6 6
Inadequacy of Device Shape and/or Size 6 6
Connection Problem 5 5
Osseointegration Problem 5 5
Material Twisted/Bent 5 5
Patient Device Interaction Problem 5 5
No Apparent Adverse Event 4 4
Patient-Device Incompatibility 4 4
Device Damaged by Another Device 4 4
Component Missing 4 4
Degraded 4 4
Material Disintegration 3 3
Shipping Damage or Problem 3 3
Device Difficult to Setup or Prepare 3 3
Material Fragmentation 3 3
Defective Device 3 3
Deformation Due to Compressive Stress 2 2
Contamination /Decontamination Problem 2 2
Difficult to Open or Close 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Device Damaged Prior to Use 2 2
Failure to Align 2 2
Dent in Material 2 2
Misassembled 2 2
Disconnection 2 2
Bent 2 2
Illegible Information 2 2
Physical Resistance/Sticking 1 1
Difficult or Delayed Separation 1 1
Therapeutic or Diagnostic Output Failure 1 1
Mechanical Jam 1 1
Material Distortion 1 1
Entrapment of Device 1 1
Difficult or Delayed Positioning 1 1
Component Incompatible 1 1
Contamination 1 1
Device Abrasion From Instrument Or Another Object 1 1
Delivered as Unsterile Product 1 1
Material Rupture 1 1
Failure to Disconnect 1 1
Failure to Advance 1 1
Defective Component 1 1
Device Contamination with Body Fluid 1 1
Problem with Sterilization 1 1
Excessive Cooling 1 1
Device Contamination with Chemical or Other Material 1 1
Device Or Device Fragments Location Unknown 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 1023 1023
Joint Dislocation 883 883
No Information 878 878
Pain 572 572
Unspecified Infection 417 417
Injury 265 265
Osteolysis 122 122
Bone Fracture(s) 104 104
No Known Impact Or Consequence To Patient 100 100
Foreign Body Reaction 99 99
Fall 93 93
No Consequences Or Impact To Patient 85 85
Insufficient Information 78 78
No Clinical Signs, Symptoms or Conditions 78 78
Reaction 77 77
Ambulation Difficulties 65 65
Not Applicable 63 63
Tissue Damage 60 60
Failure of Implant 58 58
No Patient Involvement 56 56
Limited Mobility Of The Implanted Joint 52 52
Loss of Range of Motion 52 52
Discomfort 45 45
Swelling 43 43
Test Result 42 42
Joint Laxity 42 42
Inflammation 40 40
Hematoma 36 36
Ossification 36 36
Hip Fracture 30 30
Toxicity 29 30
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 28 28
Hypersensitivity/Allergic reaction 24 24
Death 22 22
Thrombosis 17 17
Erosion 16 16
Scar Tissue 15 15
Necrosis 14 14
Pulmonary Embolism 14 14
Edema 14 14
Host-Tissue Reaction 13 13
Impaired Healing 13 13
Inadequate Osseointegration 13 13
Osteopenia/ Osteoporosis 13 13
Adhesion(s) 12 12
Metal Related Pathology 11 11
Joint Disorder 10 10
Fatigue 10 10
Cyst(s) 8 8
Weakness 8 8
Blood Loss 8 8
Unspecified Tissue Injury 8 8
Swelling/ Edema 8 8
Numbness 7 7
Disability 7 7
Nerve Damage 7 7
Hemorrhage/Bleeding 6 6
Cardiac Arrest 5 5
Wound Dehiscence 5 5
Synovitis 5 5
Peroneal Nerve Palsy 5 5
Claudication 4 4
Complaint, Ill-Defined 4 5
Anxiety 4 4
Distress 4 4
Unspecified Musculoskeletal problem 4 4
Fluid Discharge 4 4
Patient Problem/Medical Problem 4 4
Respiratory Distress 4 4
Scarring 4 4
Sepsis 4 4
Seroma 4 4
Abscess 4 4
Infarction, Cerebral 4 4
Bruise/Contusion 3 3
Arthritis 3 3
Hearing Impairment 3 3
Local Reaction 3 3
Damage to Ligament(s) 3 3
Muscle/Tendon Damage 3 3
Physical Asymmetry 3 3
Heart Failure 3 3
Chills 3 3
Nausea 2 2
Urinary Tract Infection 2 2
Visual Impairment 2 2
Arthralgia 2 2
Deformity/ Disfigurement 2 2
Sleep Dysfunction 2 2
Diaphoresis 2 2
Non-union Bone Fracture 2 2
Thrombosis/Thrombus 2 2
Limb Fracture 2 2
Device Embedded In Tissue or Plaque 2 2
Muscle Weakness 2 2
Ischemia 2 2
Neurological Deficit/Dysfunction 2 2
Paralysis 2 2
Pneumonia 2 2
Rash 2 2

Recalls
Manufacturer Recall Class Date Posted
1 DePuy Orthopaedics, Inc. II Sep-20-2012
2 Encore Medical, Lp II Apr-10-2019
3 Exactech, Inc. II Jan-18-2024
4 Exactech, Inc. II Sep-09-2022
5 Smith & Nephew Inc II Oct-18-2010
6 Smith & Nephew, Inc. II Jun-09-2015
7 Zimmer, Inc. II Nov-20-2012
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