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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
2014 323 323
2015 122 122
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 521 521
Adverse Event Without Identified Device or Use Problem 323 323
Device Dislodged or Dislocated 205 205
Fracture 119 119
Break 101 101
Appropriate Term/Code Not Available 77 77
Loose or Intermittent Connection 67 67
Naturally Worn 52 52
Loosening of Implant Not Related to Bone-Ingrowth 49 49
Device Slipped 28 28
Unintended Movement 22 22
Biocompatibility 20 20
Migration or Expulsion of Device 19 19
Unstable 18 18
Corroded 17 17
Device Operates Differently Than Expected 15 15
Degraded 11 11
Detachment Of Device Component 9 9
Material Deformation 9 9
Positioning Problem 9 9
Noise, Audible 9 9
Patient Device Interaction Problem 8 8
Material Integrity Problem 8 8
Compatibility Problem 8 8
Loss of Osseointegration 8 8
Metal Shedding Debris 7 7
Failure To Adhere Or Bond 6 6
Crack 5 5
Material Separation 5 5
Malposition of Device 5 5
Connection Problem 4 4
Migration 4 4
Inadequacy of Device Shape and/or Size 4 4
Fitting Problem 4 4
Material Erosion 4 4
Difficult to Insert 4 4
Mechanical Problem 3 3
Misassembled 3 3
Nonstandard Device 3 3
Pitted 3 3
Difficult To Position 3 3
Incomplete or Inadequate Connection 3 3
Activation, Positioning or Separation Problem 3 3
Device Damaged by Another Device 3 3
Patient-Device Incompatibility 3 3
Mechanical Jam 3 3
Separation Failure 2 2
Contamination /Decontamination Problem 2 2
Osseointegration Problem 2 2
Off-Label Use 2 2
Material Rupture 1 1
Component Missing 1 1
Dull, Blunt 1 1
Cut In Material 1 1
Failure to Osseointegrate 1 1
Improper or Incorrect Procedure or Method 1 1
Use of Device Problem 1 1
Accessory Incompatible 1 1
Material Fragmentation 1 1
Device Expiration Issue 1 1
Positioning Failure 1 1
Disconnection 1 1
Contamination 1 1
Failure to Convert to Back-Up 1 1
Loss of or Failure to Bond 1 1
Collapse 1 1
Device Handling Problem 1 1
Illegible Information 1 1
Unclear Information 1 1
Physical Resistance/Sticking 1 1
Device-Device Incompatibility 1 1
Detachment of Device or Device Component 1 1
Device Contamination with Chemical or Other Material 1 1
Material Twisted/Bent 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Injury 528 528
No Code Available 369 369
Unspecified Infection 170 170
Pain 137 137
Joint Dislocation 124 124
No Clinical Signs, Symptoms or Conditions 95 95
Bone Fracture(s) 88 88
Failure of Implant 83 83
No Information 75 75
No Known Impact Or Consequence To Patient 47 47
Metal Related Pathology 41 41
No Consequences Or Impact To Patient 32 32
Osteolysis 26 26
Hip Fracture 19 19
Inadequate Osseointegration 14 14
Loss of Range of Motion 11 11
Fall 10 10
Thrombosis/Thrombus 10 10
Insufficient Information 10 10
Test Result 9 9
Ambulation Difficulties 9 9
Necrosis 8 8
Inflammation 7 7
Discomfort 6 6
Toxicity 5 5
Implant Pain 5 5
Swelling/ Edema 4 4
Subluxation 4 4
Joint Laxity 4 4
Complaint, Ill-Defined 4 4
Swelling 3 3
Thrombosis 3 3
Hematoma 3 3
Ossification 3 3
Bacterial Infection 3 3
Unequal Limb Length 3 3
Foreign Body In Patient 3 3
Neuralgia 3 3
Non-union Bone Fracture 3 3
Joint Disorder 3 3
Post Operative Wound Infection 3 3
Tissue Breakdown 2 2
Reaction 2 2
Cyst(s) 2 2
Death 2 2
Hemorrhage/Bleeding 2 2
Muscular Rigidity 2 2
Infiltration into Tissue 2 2
Scar Tissue 2 2
Arthralgia 2 2
Deformity/ Disfigurement 1 1
Hernia 1 1
Wheal(s) 1 1
Sepsis 1 1
Staphylococcus Aureus 1 1
Tissue Damage 1 1
Ventricular Fibrillation 1 1
Synovitis 1 1
Tachycardia 1 1
Fistula 1 1
Foreign Body Sensation in Eye 1 1
Laceration(s) 1 1
Muscle Weakness 1 1
Hypersensitivity/Allergic reaction 1 1
Debris, Bone Shedding 1 1
Chest Pain 1 1
Impaired Healing 1 1
Disability 1 1
No Patient Involvement 1 1
Osteopenia/ Osteoporosis 1 1
Thromboembolism 1 1
Limited Mobility Of The Implanted Joint 1 1
Cardiovascular Insufficiency 1 1
Unspecified Heart Problem 1 1
Device Embedded In Tissue or Plaque 1 1
Unspecified Musculoskeletal problem 1 1
Skin Infection 1 1
Muscle/Tendon Damage 1 1

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