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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
Product CodeJDH
Regulation Number 888.3380
Device Class 3

MDR Year MDR Reports MDR Events
2019 354 354
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
Insufficient Information 246 246
Adverse Event Without Identified Device or Use Problem 235 235
Device Dislodged or Dislocated 82 82
Break 65 65
Fracture 48 48
Loosening of Implant Not Related to Bone-Ingrowth 48 48
Naturally Worn 41 41
Loose or Intermittent Connection 34 34
Biocompatibility 20 20
Unstable 15 15
Unintended Movement 15 15
Corroded 9 9
Appropriate Term/Code Not Available 8 8
Material Deformation 8 8
Compatibility Problem 7 7
Degraded 7 7
Loss of Osseointegration 5 5
Malposition of Device 4 4
Migration 4 4
Material Integrity Problem 4 4
Patient Device Interaction Problem 4 4
Mechanical Jam 3 3
Connection Problem 3 3
Pitted 3 3
Incomplete or Inadequate Connection 3 3
Migration or Expulsion of Device 3 3
Mechanical Problem 3 3
Activation, Positioning or Separation Problem 3 3
Contamination /Decontamination Problem 2 2
Misassembled 2 2
Material Separation 2 2
Inadequacy of Device Shape and/or Size 2 2
Separation Failure 2 2
Material Erosion 2 2
Crack 2 2
Osseointegration Problem 2 2
Fitting Problem 2 2
Difficult to Insert 1 1
Use of Device Problem 1 1
Component Missing 1 1
Material Twisted/Bent 1 1
Failure to Osseointegrate 1 1
Unclear Information 1 1
Patient-Device Incompatibility 1 1
Device Handling Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Failure to Convert to Back-Up 1 1
Illegible Information 1 1
Physical Resistance/Sticking 1 1
Off-Label Use 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Injury 400 400
Unspecified Infection 98 98
No Clinical Signs, Symptoms or Conditions 95 95
Bone Fracture(s) 68 68
Joint Dislocation 67 67
Pain 67 67
Failure of Implant 59 59
Metal Related Pathology 40 40
No Consequences Or Impact To Patient 32 32
No Known Impact Or Consequence To Patient 25 25
Osteolysis 13 13
Inadequate Osseointegration 11 11
Hip Fracture 10 10
Insufficient Information 10 10
Thrombosis/Thrombus 10 10
Ambulation Difficulties 9 9
Necrosis 7 7
Loss of Range of Motion 7 7
Discomfort 5 5
Test Result 5 5
No Information 5 5
Implant Pain 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
Post Operative Wound Infection 2 2
Ossification 2 2
Muscular Rigidity 2 2
No Code Available 2 2
Arthralgia 2 2
Death 2 2
Toxicity 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Non-union Bone Fracture 2 2
Hemorrhage/Bleeding 2 2
Tissue Breakdown 2 2
Ventricular Fibrillation 1 1
Unspecified Musculoskeletal problem 1 1
No Patient Involvement 1 1
Sepsis 1 1
Hernia 1 1
Chest Pain 1 1
Scar Tissue 1 1
Laceration(s) 1 1
Fall 1 1

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