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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, knee, femorotibial, semi-constrained, cemented, metal/polymer
Regulation Description Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.
Product CodeHRY
Regulation Number 888.3530
Device Class 2

MDR Year MDR Reports MDR Events
2021 1218 1229
2022 840 845
2023 396 404
2024 430 478
2025 300 300
2026 114 114

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1113 1118
Fracture 765 773
Adverse Event Without Identified Device or Use Problem 249 276
Detachment of Device or Device Component 227 228
Insufficient Information 135 135
Naturally Worn 120 145
Crack 110 111
Loosening of Implant Not Related to Bone-Ingrowth 81 83
Unstable 78 78
Positioning Failure 60 61
Material Deformation 57 58
Loose or Intermittent Connection 48 49
Material Fragmentation 46 46
Loss of Osseointegration 45 45
Device Dislodged or Dislocated 41 41
Connection Problem 29 30
Appropriate Term/Code Not Available 28 31
Difficult to Insert 25 25
Mechanical Jam 23 23
Component Missing 22 22
Migration 18 21
Mechanical Problem 18 18
Material Separation 16 16
Mechanics Altered 16 16
Physical Resistance/Sticking 15 15
Material Integrity Problem 15 20
Degraded 15 15
Unintended Movement 14 14
Patient-Device Incompatibility 13 13
Material Twisted/Bent 13 13
Patient Device Interaction Problem 13 13
Separation Failure 12 12
Device Markings/Labelling Problem 11 11
Incomplete or Inadequate Connection 11 11
Corroded 11 11
Device Contamination with Chemical or Other Material 10 10
Premature Separation 9 9
Positioning Problem 8 8
Failure to Align 8 8
Malposition of Device 7 7
Loss of or Failure to Bond 7 7
Dull, Blunt 6 6
Noise, Audible 6 9
Peeled/Delaminated 6 6
Material Too Rigid or Stiff 5 5
Device Damaged by Another Device 5 5
Flaked 5 5
Component Misassembled 5 5
Defective Device 5 5
Scratched Material 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2448 2485
Insufficient Information 230 232
Pain 194 216
Unspecified Infection 154 154
Failure of Implant 128 135
Loss of Range of Motion 55 56
Swelling/ Edema 38 39
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 34 34
Joint Laxity 31 32
Joint Dislocation 27 28
Ambulation Difficulties 25 25
Bone Fracture(s) 25 25
Synovitis 17 17
Foreign Body In Patient 17 17
Scar Tissue 13 17
Osteolysis 13 13
Ossification 13 14
Metal Related Pathology 11 12
Post Operative Wound Infection 11 11
Hypersensitivity/Allergic reaction 9 9
Inadequate Osseointegration 8 8
Discomfort 8 10
Inflammation 8 8
Laceration(s) 7 7
Subluxation 6 6
Muscular Rigidity 6 6
Thrombosis/Thrombus 6 6
Implant Pain 5 5
Device Embedded In Tissue or Plaque 5 5
Osteopenia/ Osteoporosis 4 6
Unspecified Tissue Injury 4 4
Adhesion(s) 4 4
Arthritis 4 4
Fall 4 4
Pulmonary Embolism 4 4
Fluid Discharge 4 4
Cellulitis 3 3
Foreign Body Reaction 3 3
Bacterial Infection 3 3
Blister 3 3
Perforation 3 4
Unspecified Musculoskeletal problem 3 4
Tissue Breakdown 3 3
Fibrosis 2 3
Granuloma 2 2
Muscle/Tendon Damage 2 2
Cyst(s) 2 2
Fatigue 2 2
Abdominal Pain 2 2
Pneumonia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Aesculap Implant Systems LLC II Sep-22-2021
2 Biomet, Inc. II Jan-26-2023
3 Exactech, Inc. II Oct-04-2021
4 MicroPort Orthopedics Inc. II Jul-01-2024
5 MicroPort Orthopedics Inc. II Nov-22-2022
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