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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)
2019 2020 2021 2022 2023 2024
17 13 18 33 19 13

MDR Year MDR Reports MDR Events
2019 641 641
2020 371 371
2021 109 109
2022 89 89
2023 134 134
2024 71 71

Device Problems MDRs with this Device Problem Events in those MDRs
Break 637 637
Adverse Event Without Identified Device or Use Problem 222 222
Fracture 195 195
Device Dislodged or Dislocated 58 58
Material Twisted/Bent 56 56
Insufficient Information 56 56
Noise, Audible 46 46
Naturally Worn 38 38
Material Deformation 32 32
Loosening of Implant Not Related to Bone-Ingrowth 26 26
Scratched Material 22 22
Crack 20 20
Device-Device Incompatibility 19 19
Loss of Osseointegration 18 18
Degraded 16 16
Osseointegration Problem 14 14
Malposition of Device 11 11
Difficult to Insert 11 11
Patient Device Interaction Problem 10 10
Biocompatibility 10 10
Appropriate Term/Code Not Available 9 9
Use of Device Problem 9 9
Migration 8 8
Loose or Intermittent Connection 7 7
Detachment of Device or Device Component 7 7
Unstable 7 7
Physical Resistance/Sticking 6 6
Corroded 5 5
Connection Problem 5 5
Unintended Movement 5 5
Failure to Osseointegrate 5 5
Positioning Failure 5 5
Difficult to Remove 5 5
Device Slipped 4 4
Unsealed Device Packaging 4 4
Component Missing 3 3
Material Fragmentation 3 3
Inadequacy of Device Shape and/or Size 3 3
Mechanical Problem 3 3
Mechanical Jam 3 3
Device Contaminated During Manufacture or Shipping 2 2
Packaging Problem 2 2
Fitting Problem 2 2
Material Frayed 2 2
Material Erosion 2 2
Patient-Device Incompatibility 2 2
Material Disintegration 2 2
Difficult to Open or Remove Packaging Material 2 2
Loss of or Failure to Bond 2 2
Delivered as Unsterile Product 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 643 643
Pain 188 188
No Code Available 172 172
Insufficient Information 89 89
No Clinical Signs, Symptoms or Conditions 78 78
Not Applicable 73 73
Unspecified Infection 71 71
Failure of Implant 62 62
Injury 52 52
Joint Dislocation 49 49
Metal Related Pathology 46 46
Bone Fracture(s) 28 28
Ambulation Difficulties 26 26
Foreign Body Reaction 25 25
Inadequate Osseointegration 23 23
Osteolysis 21 21
Loss of Range of Motion 19 19
No Information 19 19
Discomfort 18 18
Inflammation 14 14
Ossification 13 13
No Known Impact Or Consequence To Patient 13 13
Joint Laxity 12 12
Tissue Damage 12 12
Muscle/Tendon Damage 11 11
Foreign Body In Patient 11 11
Test Result 10 10
Scar Tissue 10 10
Limited Mobility Of The Implanted Joint 10 10
Swelling/ Edema 10 10
Adhesion(s) 9 9
Hypersensitivity/Allergic reaction 9 9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 9 9
Fall 8 8
Hematoma 8 8
Synovitis 8 8
Reaction 7 7
Cyst(s) 7 7
Blood Loss 7 7
Unequal Limb Length 6 6
Unspecified Tissue Injury 6 6
Edema 6 6
Hip Fracture 6 6
Thrombosis/Thrombus 5 5
Swelling 5 5
Limb Fracture 5 5
Myocardial Infarction 5 5
Post Operative Wound Infection 4 4
Nerve Damage 4 4
Physical Asymmetry 4 4

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