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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, hip, semi-constrained, metal/polymer, uncemented
Regulation Description Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
Product CodeLWJ
Regulation Number 888.3360
Device Class 2

MDR Year MDR Reports MDR Events
2020 189 189
2021 155 155
2022 91 91
2023 72 72
2024 54 54
2025 21 21

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 128 128
Break 109 109
Insufficient Information 63 63
Device Dislodged or Dislocated 61 61
Fracture 53 53
Loss of Osseointegration 23 23
Osseointegration Problem 23 23
Corroded 20 20
Detachment of Device or Device Component 14 14
Mechanical Problem 12 12
Appropriate Term/Code Not Available 12 12
Migration 10 10
Mechanical Jam 10 10
Naturally Worn 8 8
Difficult to Remove 7 7
Degraded 7 7
No Apparent Adverse Event 7 7
Use of Device Problem 6 6
Material Integrity Problem 6 6
Biocompatibility 5 5
Loosening of Implant Not Related to Bone-Ingrowth 5 5
Patient Device Interaction Problem 5 5
Loose or Intermittent Connection 5 5
Compatibility Problem 4 4
Device Appears to Trigger Rejection 4 4
Physical Resistance/Sticking 4 4
Material Fragmentation 3 3
Material Disintegration 3 3
Packaging Problem 3 3
Failure to Osseointegrate 3 3
Noise, Audible 3 3
Tear, Rip or Hole in Device Packaging 3 3
Delivered as Unsterile Product 3 3
Patient-Device Incompatibility 3 3
Inadequacy of Device Shape and/or Size 2 2
Entrapment of Device 2 2
Scratched Material 2 2
Unstable 2 2
Device Fell 2 2
Migration or Expulsion of Device 2 2
Malposition of Device 2 2
Unexpected Therapeutic Results 1 1
Expulsion 1 1
Improper or Incorrect Procedure or Method 1 1
Fitting Problem 1 1
Device-Device Incompatibility 1 1
Connection Problem 1 1
Component or Accessory Incompatibility 1 1
Defective Device 1 1
Separation Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 97 97
Pain 79 79
No Clinical Signs, Symptoms or Conditions 69 69
No Information 62 62
Failure of Implant 58 58
Bone Fracture(s) 56 56
Unspecified Infection 39 39
Inadequate Osseointegration 28 28
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 27 27
Metal Related Pathology 22 22
No Code Available 20 20
Joint Dislocation 17 17
Foreign Body Reaction 13 13
Loss of Range of Motion 13 13
Osteolysis 13 13
Joint Laxity 12 12
Limb Fracture 11 11
Fall 11 11
No Known Impact Or Consequence To Patient 9 9
Hypersensitivity/Allergic reaction 9 9
Hip Fracture 9 9
Unequal Limb Length 7 7
Joint Disorder 7 7
Injury 7 7
Patient Problem/Medical Problem 6 6
Discomfort 6 6
Bacterial Infection 5 5
Ambulation Difficulties 5 5
Swelling/ Edema 4 4
Unspecified Tissue Injury 4 4
Inflammation 4 4
Necrosis 4 4
Wound Dehiscence 4 4
Foreign Body In Patient 3 3
Synovitis 3 3
Swelling 3 3
Fatigue 3 3
Implant Pain 2 2
Test Result 2 2
Subluxation 2 2
Device Embedded In Tissue or Plaque 2 2
Fibrosis 2 2
Hemorrhage/Bleeding 2 2
Hematoma 2 2
Thrombosis/Thrombus 2 2
Fever 2 2
Edema 2 2
Dyspnea 2 2
Ossification 2 2
Shaking/Tremors 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Howmedica Osteonics Corp. II Jan-31-2024
2 MicroPort Orthopedics Inc. I Sep-18-2020
3 MicroPort Orthopedics Inc. II Sep-09-2020
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