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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)
2021 2022 2023 2024 2025 2026
18 33 19 16 18 1

MDR Year MDR Reports MDR Events
2021 109 113
2022 89 96
2023 132 140
2024 118 120
2025 92 1133
2026 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 196 1066
Adverse Event Without Identified Device or Use Problem 184 1229
Device Dislodged or Dislocated 34 208
Noise, Audible 27 28
Loosening of Implant Not Related to Bone-Ingrowth 27 1073
Osseointegration Problem 19 1065
Break 15 15
Insufficient Information 13 13
Difficult to Insert 12 12
Naturally Worn 11 11
Patient Device Interaction Problem 10 11
Degraded 9 10
Loss of Osseointegration 8 8
Material Erosion 8 869
Biocompatibility 7 7
Migration 6 6
Use of Device Problem 6 6
Malposition of Device 5 877
Detachment of Device or Device Component 5 5
Unstable 4 4
Improper or Incorrect Procedure or Method 4 695
Unsealed Device Packaging 4 4
Failure to Osseointegrate 4 5
Corroded 3 3
Appropriate Term/Code Not Available 3 3
Delivered as Unsterile Product 3 3
Positioning Failure 3 3
Tear, Rip or Hole in Device Packaging 2 2
Packaging Problem 2 2
Positioning Problem 2 2
Patient-Device Incompatibility 2 2
Device Damaged Prior to Use 2 2
Mechanical Problem 2 4
Material Frayed 2 2
Difficult to Remove 1 2
Material Deformation 1 1
Inadequacy of Device Shape and/or Size 1 1
Material Integrity Problem 1 1
Separation Failure 1 1
Crack 1 1
Physical Resistance/Sticking 1 1
Device Appears to Trigger Rejection 1 1
Difficult to Open or Remove Packaging Material 1 1
Inaccurate Information 1 1
Off-Label Use 1 1
Loose or Intermittent Connection 1 1
Mechanical Jam 1 1
Device Contaminated During Manufacture or Shipping 1 1
Device-Device Incompatibility 1 1
Device Slipped 1 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 125 1169
Pain 117 989
No Clinical Signs, Symptoms or Conditions 112 114
Failure of Implant 62 70
Unspecified Infection 48 1090
Joint Dislocation 45 1088
Metal Related Pathology 45 740
Bone Fracture(s) 23 204
Ambulation Difficulties 20 22
Osteolysis 18 881
Joint Laxity 16 888
Inadequate Osseointegration 14 879
Loss of Range of Motion 14 17
Muscle/Tendon Damage 12 14
Foreign Body Reaction 12 13
Swelling/ Edema 11 13
Discomfort 10 12
Ossification 10 701
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 9 10
Unequal Limb Length 9 872
Cyst(s) 7 7
Fall 7 8
Hip Fracture 7 7
Unspecified Tissue Injury 7 8
Synovitis 6 6
Thrombosis/Thrombus 6 6
Foreign Body In Patient 6 7
Adhesion(s) 5 5
Inflammation 5 5
Deformity/ Disfigurement 5 1048
Physical Asymmetry 5 5
Limb Fracture 5 5
Nerve Damage 4 4
Scar Tissue 4 6
Local Reaction 3 174
Sepsis 3 3
Hypersensitivity/Allergic reaction 3 3
Unspecified Musculoskeletal problem 2 2
Hematoma 2 2
Pulmonary Embolism 2 2
Cellulitis 2 2
Post Operative Wound Infection 2 2
Fever 2 2
Hemorrhage/Bleeding 2 2
Arthralgia 2 2
Subluxation 2 2
Nodule 2 2
Distress 1 2
Respiratory Failure 1 1
Arthritis 1 1

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