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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
2020 292 292
2021 158 158
2022 75 75
2023 5 5
2024 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 229 229
Insufficient Information 66 66
Break 44 44
Loosening of Implant Not Related to Bone-Ingrowth 42 42
Naturally Worn 40 40
Fracture 27 27
Device Dislodged or Dislocated 25 25
Biocompatibility 20 20
Unintended Movement 13 13
Loose or Intermittent Connection 10 10
Corroded 9 9
Unstable 8 8
Compatibility Problem 7 7
Loss of Osseointegration 5 5
Appropriate Term/Code Not Available 4 4
Migration 4 4
Activation, Positioning or Separation Problem 3 3
Malposition of Device 3 3
Incomplete or Inadequate Connection 3 3
Mechanical Jam 3 3
Patient Device Interaction Problem 3 3
Degraded 3 3
Osseointegration Problem 2 2
Connection Problem 2 2
Inadequacy of Device Shape and/or Size 2 2
Material Deformation 2 2
Separation Failure 2 2
Material Erosion 2 2
Crack 2 2
Migration or Expulsion of Device 2 2
Mechanical Problem 2 2
Material Separation 1 1
Device Contamination with Chemical or Other Material 1 1
Failure to Osseointegrate 1 1
Material Twisted/Bent 1 1
Use of Device Problem 1 1
Difficult to Insert 1 1
Unclear Information 1 1
Failure to Convert to Back-Up 1 1
Dull, Blunt 1 1
Fitting Problem 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Injury 181 181
No Clinical Signs, Symptoms or Conditions 95 95
Failure of Implant 59 59
Joint Dislocation 51 51
Unspecified Infection 48 48
Pain 44 44
Bone Fracture(s) 42 42
Metal Related Pathology 40 40
No Known Impact Or Consequence To Patient 22 22
Osteolysis 13 13
Inadequate Osseointegration 11 11
Insufficient Information 10 10
Thrombosis/Thrombus 10 10
Hip Fracture 10 10
Ambulation Difficulties 9 9
No Consequences Or Impact To Patient 9 9
Loss of Range of Motion 7 7
Necrosis 6 6
No Information 5 5
Implant Pain 5 5
Discomfort 5 5
Swelling/ Edema 4 4
Joint Laxity 4 4
Subluxation 4 4
Inflammation 4 4
Foreign Body In Patient 3 3
Thrombosis 3 3
Unequal Limb Length 3 3
Neuralgia 3 3
Arthralgia 2 2
Muscular Rigidity 2 2
Post Operative Wound Infection 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Ossification 2 2
Non-union Bone Fracture 2 2
Tissue Breakdown 2 2
Ventricular Fibrillation 1 1
Chest Pain 1 1
Sepsis 1 1
Hernia 1 1
No Patient Involvement 1 1
Skin Infection 1 1
Fall 1 1
Laceration(s) 1 1
Impaired Healing 1 1
Scar Tissue 1 1
Muscle/Tendon Damage 1 1
Tachycardia 1 1
No Code Available 1 1
Tissue Damage 1 1

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