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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
2016 94 94
2017 82 82
2018 223 223
2019 354 354
2020 292 292
2021 158 158
2022 76 76
2023 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 385 385
Adverse Event Without Identified Device or Use Problem 290 290
Device Dislodged or Dislocated 132 132
Break 85 85
Fracture 78 78
Loosening of Implant Not Related to Bone-Ingrowth 49 49
Naturally Worn 46 46
Loose or Intermittent Connection 42 42
Appropriate Term/Code Not Available 31 31
Unintended Movement 22 22
Biocompatibility 20 20
Corroded 15 15
Unstable 15 15
Degraded 10 10
Migration or Expulsion of Device 10 10
Material Deformation 9 9
Patient Device Interaction Problem 8 8
Detachment Of Device Component 8 8
Loss of Osseointegration 7 7
Material Integrity Problem 7 7
Compatibility Problem 7 7
Noise, Audible 6 6
Metal Shedding Debris 6 6
Device Operates Differently Than Expected 5 5
Connection Problem 4 4
Migration 4 4
Malposition of Device 4 4
Device Slipped 4 4
Material Separation 4 4
Material Erosion 4 4
Misassembled 3 3
Mechanical Problem 3 3
Failure To Adhere Or Bond 3 3
Crack 3 3
Pitted 3 3
Patient-Device Incompatibility 3 3
Fitting Problem 3 3
Incomplete or Inadequate Connection 3 3
Activation, Positioning or Separation Problem 3 3
Device Damaged by Another Device 3 3
Mechanical Jam 3 3
Positioning Problem 3 3
Osseointegration Problem 2 2
Contamination /Decontamination Problem 2 2
Separation Failure 2 2
Off-Label Use 2 2
Inadequacy of Device Shape and/or Size 2 2
Material Rupture 1 1
Accessory Incompatible 1 1
Use of Device Problem 1 1
Component Missing 1 1
Dull, Blunt 1 1
Failure to Osseointegrate 1 1
Positioning Failure 1 1
Disconnection 1 1
Failure to Convert to Back-Up 1 1
Loss of or Failure to Bond 1 1
Nonstandard Device 1 1
Device Expiration Issue 1 1
Material Fragmentation 1 1
Difficult to Insert 1 1
Detachment of Device or Device Component 1 1
Device-Device Incompatibility 1 1
Device Contamination with Chemical or Other Material 1 1
Material Twisted/Bent 1 1
Illegible Information 1 1
Unclear Information 1 1
Physical Resistance/Sticking 1 1
Device Handling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Injury 526 526
Unspecified Infection 145 145
Joint Dislocation 108 108
Pain 104 104
No Clinical Signs, Symptoms or Conditions 95 95
Failure of Implant 82 82
Bone Fracture(s) 79 79
No Code Available 60 60
No Information 50 50
Metal Related Pathology 41 41
No Known Impact Or Consequence To Patient 40 40
No Consequences Or Impact To Patient 32 32
Hip Fracture 19 19
Osteolysis 17 17
Inadequate Osseointegration 12 12
Thrombosis/Thrombus 10 10
Insufficient Information 10 10
Loss of Range of Motion 10 10
Necrosis 8 8
Test Result 8 8
Ambulation Difficulties 8 8
Inflammation 6 6
Discomfort 5 5
Implant Pain 5 5
Swelling/ Edema 4 4
Subluxation 4 4
Joint Laxity 4 4
Fall 4 4
Hematoma 3 3
Ossification 3 3
Toxicity 3 3
Thrombosis 3 3
Neuralgia 3 3
Unequal Limb Length 3 3
Foreign Body In Patient 3 3
Non-union Bone Fracture 3 3
Joint Disorder 3 3
Post Operative Wound Infection 3 3
Tissue Breakdown 2 2
Scar Tissue 2 2
Arthralgia 2 2
Bacterial Infection 2 2
Cyst(s) 2 2
Death 2 2
Hemorrhage/Bleeding 2 2
Muscular Rigidity 2 2
Laceration(s) 1 1
Muscle Weakness 1 1
Fistula 1 1
Foreign Body Sensation in Eye 1 1
Infiltration into Tissue 1 1
Hypersensitivity/Allergic reaction 1 1
Debris, Bone Shedding 1 1
Chest Pain 1 1
Deformity/ Disfigurement 1 1
Complaint, Ill-Defined 1 1
Sepsis 1 1
Swelling 1 1
Synovitis 1 1
Tachycardia 1 1
Tissue Damage 1 1
Ventricular Fibrillation 1 1
Hernia 1 1
Wheal(s) 1 1
No Patient Involvement 1 1
Osteopenia/ Osteoporosis 1 1
Thromboembolism 1 1
Limited Mobility Of The Implanted Joint 1 1
Disability 1 1
Impaired Healing 1 1
Reaction 1 1
Unspecified Musculoskeletal problem 1 1
Skin Infection 1 1
Muscle/Tendon Damage 1 1
Cardiovascular Insufficiency 1 1
Unspecified Heart Problem 1 1

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