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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 76 76
2023 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 246 246
Adverse Event Without Identified Device or Use Problem 232 232
Device Dislodged or Dislocated 82 82
Break 65 65
Fracture 48 48
Loosening of Implant Not Related to Bone-Ingrowth 47 47
Naturally Worn 40 40
Loose or Intermittent Connection 34 34
Biocompatibility 20 20
Unstable 15 15
Unintended Movement 15 15
Corroded 9 9
Material Deformation 8 8
Appropriate Term/Code Not Available 8 8
Compatibility Problem 7 7
Degraded 6 6
Loss of Osseointegration 5 5
Patient Device Interaction Problem 5 5
Migration 4 4
Malposition of Device 4 4
Material Integrity Problem 4 4
Connection Problem 3 3
Activation, Positioning or Separation Problem 3 3
Mechanical Problem 3 3
Migration or Expulsion of Device 3 3
Pitted 3 3
Incomplete or Inadequate Connection 3 3
Mechanical Jam 3 3
Osseointegration Problem 2 2
Material Separation 2 2
Inadequacy of Device Shape and/or Size 2 2
Misassembled 2 2
Material Erosion 2 2
Crack 2 2
Contamination /Decontamination Problem 2 2
Separation Failure 2 2
Fitting Problem 2 2
Component Missing 1 1
Dull, Blunt 1 1
Patient-Device Incompatibility 1 1
Device Contamination with Chemical or Other Material 1 1
Material Twisted/Bent 1 1
Failure to Convert to Back-Up 1 1
Use of Device Problem 1 1
Failure to Osseointegrate 1 1
Off-Label Use 1 1
Difficult to Insert 1 1
Device Handling Problem 1 1
Noise, Audible 1 1
Illegible Information 1 1
Unclear Information 1 1
Physical Resistance/Sticking 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
Pain 66 66
Joint Dislocation 64 64
Failure of Implant 58 58
Metal Related Pathology 41 41
No Consequences Or Impact To Patient 32 32
No Known Impact Or Consequence To Patient 25 25
Osteolysis 12 12
Inadequate Osseointegration 11 11
Thrombosis/Thrombus 10 10
Insufficient Information 10 10
Hip Fracture 10 10
Ambulation Difficulties 8 8
Necrosis 8 8
Loss of Range of Motion 8 8
Discomfort 5 5
Implant Pain 5 5
Test Result 5 5
No Information 5 5
Subluxation 4 4
Joint Laxity 4 4
Swelling/ Edema 4 4
Inflammation 4 4
Thrombosis 3 3
Unequal Limb Length 3 3
Foreign Body In Patient 3 3
Neuralgia 3 3
No Code Available 2 2
Post Operative Wound Infection 2 2
Tissue Breakdown 2 2
Arthralgia 2 2
Toxicity 2 2
Non-union Bone Fracture 2 2
Muscular Rigidity 2 2
Scar Tissue 2 2
Hemorrhage/Bleeding 2 2
Ossification 2 2
Bacterial Infection 2 2
Death 2 2
Debris, Bone Shedding 1 1
Fall 1 1
Chest Pain 1 1
Infiltration into Tissue 1 1
Sepsis 1 1
Synovitis 1 1
Tachycardia 1 1
Laceration(s) 1 1
Muscle Weakness 1 1
No Patient Involvement 1 1
Impaired Healing 1 1
Deformity/ Disfigurement 1 1
Tissue Damage 1 1
Ventricular Fibrillation 1 1
Hernia 1 1
Osteopenia/ Osteoporosis 1 1
Thromboembolism 1 1
Cardiovascular Insufficiency 1 1
Unspecified Heart Problem 1 1
Muscle/Tendon Damage 1 1
Unspecified Musculoskeletal problem 1 1
Skin Infection 1 1

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