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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 4

MDR Year MDR Reports MDR Events
2021 109 113
2022 89 96
2023 132 140
2024 118 120
2025 92 1133
2026 44 44

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 215 1085
Adverse Event Without Identified Device or Use Problem 189 1234
Device Dislodged or Dislocated 35 209
Noise, Audible 28 29
Loosening of Implant Not Related to Bone-Ingrowth 27 1073
Osseointegration Problem 19 1065
Break 16 16
Insufficient Information 14 14
Difficult to Insert 14 14
Naturally Worn 12 12
Patient Device Interaction Problem 10 11
Degraded 9 10
Biocompatibility 8 8
Loss of Osseointegration 8 8
Material Erosion 8 869
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
Difficult to Remove 2 3
Positioning Problem 2 2
Patient-Device Incompatibility 2 2
Device Damaged Prior to Use 2 2
Mechanical Problem 2 4
Material Frayed 2 2
Material Deformation 1 1
Inadequacy of Device Shape and/or Size 1 1
Material Integrity Problem 1 1
No Apparent Adverse Event 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

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 134 1178
No Clinical Signs, Symptoms or Conditions 126 128
Pain 118 990
Failure of Implant 63 71
Unspecified Infection 51 1093
Metal Related Pathology 46 741
Joint Dislocation 45 1088
Bone Fracture(s) 23 204
Ambulation Difficulties 20 22
Osteolysis 18 881
Joint Laxity 17 889
Loss of Range of Motion 14 17
Inadequate Osseointegration 14 879
Foreign Body Reaction 12 13
Muscle/Tendon Damage 12 14
Swelling/ Edema 11 13
Discomfort 11 13
Ossification 10 701
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 9 10
Unequal Limb Length 9 872
Unspecified Tissue Injury 8 9
Cyst(s) 7 7
Fall 7 8
Hip Fracture 7 7
Synovitis 6 6
Foreign Body In Patient 6 7
Thrombosis/Thrombus 6 6
Adhesion(s) 5 5
Physical Asymmetry 5 5
Inflammation 5 5
Deformity/ Disfigurement 5 1048
Limb Fracture 5 5
Scar Tissue 4 6
Nerve Damage 4 4
Hypersensitivity/Allergic reaction 4 4
Sepsis 3 3
Local Reaction 3 174
Nodule 2 2
Hemorrhage/Bleeding 2 2
Subluxation 2 2
Pulmonary Embolism 2 2
Fever 2 2
Post Operative Wound Infection 2 2
Cellulitis 2 2
Hematoma 2 2
Unspecified Musculoskeletal problem 2 2
Arthralgia 2 2
Numbness 1 1
Septic Shock 1 1
Ecchymosis 1 1

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