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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)
2020 2021 2022 2023 2024 2025
13 18 33 19 16 17

MDR Year MDR Reports MDR Events
2020 371 371
2021 109 109
2022 89 89
2023 132 133
2024 118 118
2025 82 1123

Device Problems MDRs with this Device Problem Events in those MDRs
Break 228 228
Adverse Event Without Identified Device or Use Problem 217 1259
Fracture 213 1076
Device Dislodged or Dislocated 46 218
Noise, Audible 41 41
Material Twisted/Bent 32 32
Insufficient Information 26 26
Loosening of Implant Not Related to Bone-Ingrowth 26 1070
Osseointegration Problem 18 1062
Naturally Worn 16 16
Loss of Osseointegration 14 14
Degraded 12 12
Difficult to Insert 11 11
Patient Device Interaction Problem 10 10
Device-Device Incompatibility 9 9
Crack 8 8
Material Erosion 8 869
Use of Device Problem 8 8
Unstable 7 7
Biocompatibility 7 7
Malposition of Device 7 879
Material Deformation 7 7
Appropriate Term/Code Not Available 6 6
Migration 6 6
Detachment of Device or Device Component 5 5
Failure to Osseointegrate 5 5
Device Slipped 4 4
Improper or Incorrect Procedure or Method 4 695
Unsealed Device Packaging 4 4
Difficult to Remove 4 4
Loose or Intermittent Connection 3 3
Corroded 3 3
Delivered as Unsterile Product 3 3
Positioning Failure 3 3
Unintended Movement 3 3
Component Missing 2 2
Packaging Problem 2 2
Inadequacy of Device Shape and/or Size 2 2
Tear, Rip or Hole in Device Packaging 2 2
Positioning Problem 2 2
Patient-Device Incompatibility 2 2
Connection Problem 2 2
Device Damaged Prior to Use 2 2
Difficult to Open or Remove Packaging Material 2 2
Mechanical Problem 2 2
Device Contaminated During Manufacture or Shipping 2 2
Material Frayed 2 2
Device Damaged by Another Device 1 1
Contamination /Decontamination Problem 1 1
Material Integrity Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 233 233
Pain 152 1014
Insufficient Information 123 1164
No Clinical Signs, Symptoms or Conditions 114 114
No Code Available 108 108
Failure of Implant 67 68
Unspecified Infection 59 1101
Joint Dislocation 53 1095
Metal Related Pathology 46 737
Bone Fracture(s) 29 210
Ambulation Difficulties 22 23
Osteolysis 22 885
Injury 19 19
Inadequate Osseointegration 18 882
Foreign Body Reaction 18 18
Joint Laxity 17 889
Loss of Range of Motion 17 17
Not Applicable 14 14
Discomfort 14 14
Muscle/Tendon Damage 12 12
Swelling/ Edema 11 11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 10 10
Unequal Limb Length 10 873
Ossification 10 701
Fall 9 9
No Information 9 9
Hip Fracture 8 8
Unspecified Tissue Injury 7 7
Cyst(s) 7 7
Foreign Body In Patient 7 7
Synovitis 7 7
Thrombosis/Thrombus 6 6
Inflammation 6 6
Adhesion(s) 6 6
Limited Mobility Of The Implanted Joint 6 6
Edema 5 5
Deformity/ Disfigurement 5 1048
Scar Tissue 5 5
Physical Asymmetry 5 5
Limb Fracture 5 5
Arthralgia 5 5
No Known Impact Or Consequence To Patient 4 4
Nerve Damage 4 4
Hypersensitivity/Allergic reaction 4 4
Local Reaction 3 174
Test Result 3 3
Cellulitis 2 2
Impaired Healing 2 2
Post Operative Wound Infection 2 2
Fever 2 2

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