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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, hip, hemi-, trunnion-bearing, femoral, metal/polyacetal
Regulation Description Hip joint femoral (hemi-hip) trunnion-bearing metal/polyacetal cemented prosthesis.
Product CodeJDH
Regulation Number 888.3380
Device Class 3

MDR Year MDR Reports MDR Events
2021 158 158
2022 75 76
2023 5 5
2024 6 6
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 113 113
Naturally Worn 39 39
Loosening of Implant Not Related to Bone-Ingrowth 37 37
Biocompatibility 18 18
Break 14 14
Fracture 14 14
Device Dislodged or Dislocated 11 11
Corroded 9 9
Loose or Intermittent Connection 7 7
Loss of Osseointegration 5 5
Migration 4 4
Malposition of Device 2 2
Crack 2 2
Material Erosion 2 2
Separation Failure 2 2
Degraded 2 2
Material Deformation 2 2
Inadequacy of Device Shape and/or Size 2 2
Connection Problem 2 2
Mechanical Jam 2 2
Unstable 1 1
Fitting Problem 1 1
Incomplete or Inadequate Connection 1 1
Insufficient Information 1 1
Difficult to Insert 1 1
Use of Device Problem 1 2
Material Twisted/Bent 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 86 86
Failure of Implant 46 46
Joint Dislocation 33 33
Metal Related Pathology 29 29
Bone Fracture(s) 20 20
Unspecified Infection 19 19
Pain 18 18
Osteolysis 12 12
Inadequate Osseointegration 10 10
Thrombosis/Thrombus 10 10
Ambulation Difficulties 8 8
Insufficient Information 8 8
Necrosis 6 6
Hip Fracture 5 5
Implant Pain 5 5
Discomfort 5 5
Inflammation 4 4
Loss of Range of Motion 4 4
Swelling/ Edema 3 3
Tissue Breakdown 2 2
Non-union Bone Fracture 2 2
Subluxation 2 3
Post Operative Wound Infection 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Chest Pain 1 1
Hernia 1 1
Foreign Body In Patient 1 1
Ventricular Fibrillation 1 1
Fall 1 1
Laceration(s) 1 1
Ossification 1 1
Unspecified Musculoskeletal problem 1 1
Muscle/Tendon Damage 1 1
Tachycardia 1 1
Sepsis 1 1
Joint Laxity 1 2
Cardiovascular Insufficiency 1 1
Unspecified Heart Problem 1 1
Bacterial Infection 1 1
Hemorrhage/Bleeding 1 1
Infiltration into Tissue 1 1
Deformity/ Disfigurement 1 1
Thromboembolism 1 1
Skin Infection 1 1
Impaired Healing 1 1

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