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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Product CodeMRA
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
14 14 12 28 17 9 18 26 16 11 17 13 18 33 19 6

MDR Year MDR Reports MDR Events
2014 280 280
2015 328 328
2016 367 367
2017 540 540
2018 696 696
2019 641 641
2020 371 371
2021 109 109
2022 89 89
2023 134 134
2024 34 34

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1472 1472
Insufficient Information 476 476
Fracture 424 424
Adverse Event Without Identified Device or Use Problem 298 298
Device Dislodged or Dislocated 197 197
Noise, Audible 148 148
Appropriate Term/Code Not Available 115 115
Loss of Osseointegration 78 78
Crack 73 73
Naturally Worn 68 68
Material Twisted/Bent 57 57
Malposition of Device 47 47
Material Deformation 44 44
Migration or Expulsion of Device 39 39
Loose or Intermittent Connection 38 38
Disassembly 34 34
Osseointegration Problem 29 29
Scratched Material 27 27
Loosening of Implant Not Related to Bone-Ingrowth 25 25
Corroded 25 25
Device-Device Incompatibility 23 23
Unstable 21 21
Degraded 21 21
Difficult to Remove 19 19
Mechanical Problem 16 16
Device Operates Differently Than Expected 16 16
Difficult to Insert 15 15
Loss of or Failure to Bond 14 14
Inadequacy of Device Shape and/or Size 13 13
Metal Shedding Debris 13 13
Connection Problem 12 12
Use of Device Problem 11 11
Material Fragmentation 10 10
Patient Device Interaction Problem 10 10
Material Integrity Problem 10 10
Device Slipped 9 9
Fitting Problem 9 9
Detachment of Device or Device Component 8 8
Unintended Movement 8 8
Migration 7 7
Positioning Problem 7 7
Biocompatibility 7 7
Failure To Adhere Or Bond 7 7
Failure to Disconnect 6 6
Physical Resistance/Sticking 6 6
Mechanical Jam 5 5
Failure to Osseointegrate 5 5
Patient-Device Incompatibility 5 5
Positioning Failure 5 5
Detachment Of Device Component 4 4
Material Erosion 4 4
Unsealed Device Packaging 4 4
Device Contaminated During Manufacture or Shipping 4 4
Component Missing 4 4
Dull, Blunt 3 3
Device Inoperable 3 3
Material Discolored 3 3
Material Disintegration 3 3
Packaging Problem 3 3
Material Frayed 2 2
Bent 2 2
Peeled/Delaminated 2 2
Difficult To Position 2 2
Device Damaged by Another Device 2 2
Device Damaged Prior to Use 2 2
Improper or Incorrect Procedure or Method 2 2
Defective Device 2 2
Device Displays Incorrect Message 1 1
Separation Failure 1 1
Failure to Align 1 1
Failure to Advance 1 1
Dent in Material 1 1
Defective Component 1 1
Out-Of-Box Failure 1 1
Device Issue 1 1
Device Disinfection Or Sterilization Issue 1 1
Ambient Noise Problem 1 1
Contamination /Decontamination Problem 1 1
Material Distortion 1 1
Difficult to Open or Remove Packaging Material 1 1
Device Contamination with Chemical or Other Material 1 1
Device Difficult to Setup or Prepare 1 1
Off-Label Use 1 1
Device Appears to Trigger Rejection 1 1
Device Abrasion From Instrument Or Another Object 1 1
Incorrect Measurement 1 1
Unexpected Therapeutic Results 1 1
Material Separation 1 1
Misconnection 1 1
Unintended Collision 1 1
Component Incompatible 1 1
Flaked 1 1
Entrapment of Device 1 1
Disconnection 1 1
Mechanics Altered 1 1
Moisture or Humidity Problem 1 1
No Pressure 1 1
Activation Problem 1 1
Separation Problem 1 1
Material Split, Cut or Torn 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 1156 1156
No Information 628 628
Pain 498 498
No Code Available 378 378
Unspecified Infection 216 216
No Known Impact Or Consequence To Patient 203 203
Injury 194 194
Not Applicable 137 137
Bone Fracture(s) 113 113
Joint Dislocation 96 96
Insufficient Information 78 78
No Clinical Signs, Symptoms or Conditions 73 73
Failure of Implant 73 73
Discomfort 60 60
Device Embedded In Tissue or Plaque 53 53
Inadequate Osseointegration 49 49
Foreign Body Reaction 49 49
Metal Related Pathology 43 43
Ambulation Difficulties 42 42
Inflammation 38 38
Osteolysis 38 38
Reaction 36 36
Fall 36 36
Tissue Damage 35 35
Loss of Range of Motion 28 28
Limited Mobility Of The Implanted Joint 26 26
Host-Tissue Reaction 22 22
Swelling 21 21
Test Result 20 20
Joint Disorder 16 16
Hypersensitivity/Allergic reaction 15 15
Ossification 14 14
Foreign Body In Patient 13 13
Joint Laxity 12 12
Hematoma 12 12
Scar Tissue 12 12
Necrosis 12 12
Muscle/Tendon Damage 11 11
Swelling/ Edema 10 10
Hip Fracture 10 10
Edema 10 10
Synovitis 9 9
Weakness 9 9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 9 9
Blood Loss 9 9
Adhesion(s) 8 8
Cyst(s) 8 8
Toxicity 7 7
Death 6 6
No Patient Involvement 6 6
Unspecified Tissue Injury 6 6
Unequal Limb Length 5 5
Post Operative Wound Infection 5 5
Thrombosis/Thrombus 5 5
Myocardial Infarction 5 5
Nerve Damage 4 4
Rash 4 4
Arthralgia 4 4
Fever 4 4
Muscular Rigidity 4 4
Limb Fracture 4 4
Physical Asymmetry 4 4
High Blood Pressure/ Hypertension 3 3
Hemorrhage/Bleeding 3 3
Bacterial Infection 3 3
Infarction, Cerebral 3 3
Abscess 3 3
Skin Irritation 3 3
Thrombosis 3 3
Staphylococcus Aureus 2 2
Nausea 2 2
Chills 2 2
Depression 2 2
Distress 2 2
Numbness 2 2
Impaired Healing 2 2
Calcium Deposits/Calcification 2 2
Cardiac Arrest 2 2
Fatigue 2 2
Unspecified Musculoskeletal problem 2 2
Nodule 2 2
Implant Pain 2 2
Subluxation 2 2
Cancer 1 1
Fibrosis 1 1
Fluid Discharge 1 1
Nervous System Injury 1 1
Malunion of Bone 1 1
Hyperplasia 1 1
Granuloma 1 1
Headache 1 1
Infiltration into Tissue 1 1
Cellulitis 1 1
Stroke/CVA 1 1
Anemia 1 1
Arthritis 1 1
Chest Pain 1 1
Erosion 1 1
Debris, Bone Shedding 1 1
Ecchymosis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Exactech, Inc. II Jun-02-2016
2 Smith & Nephew Inc II Apr-22-2011
3 Stryker Howmedica Osteonics Corp. II Aug-04-2009
4 Zimmer, Inc. II Feb-20-2014
5 Zimmer, Inc. II Feb-04-2013
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