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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device prosthesis, knee, femorotibial, semi-constrained, cemented, metal/polymer
Product CodeHRY
Regulation Number 888.3530
Device Class 2


Premarket Reviews
ManufacturerDecision
DEPUY IRELAND UC
  SUBSTANTIALLY EQUIVALENT 1
NANOORTHO, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 367 367
2020 1055 1055
2021 1219 1219
2022 842 842
2023 401 401
2024 67 67

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1433 1433
Fracture 475 475
Adverse Event Without Identified Device or Use Problem 371 371
Loosening of Implant Not Related to Bone-Ingrowth 204 204
Insufficient Information 200 200
Naturally Worn 143 143
Crack 141 141
Detachment of Device or Device Component 127 127
Unstable 125 125
Loose or Intermittent Connection 80 80
Material Deformation 69 69
Connection Problem 64 64
Loss of Osseointegration 56 56
Appropriate Term/Code Not Available 53 53
Device Dislodged or Dislocated 46 46
Positioning Failure 43 43
Material Fragmentation 41 41
Component Missing 40 40
Defective Device 39 39
Mechanical Jam 39 39
Dull, Blunt 37 37
Mechanical Problem 37 37
Difficult to Insert 30 30
Material Separation 28 28
Migration 28 28
Patient Device Interaction Problem 24 24
Loss of or Failure to Bond 23 23
Incomplete or Inadequate Connection 22 22
Material Twisted/Bent 22 22
Device Contamination with Chemical or Other Material 21 21
Malposition of Device 21 21
Noise, Audible 20 20
Unintended Movement 20 20
Material Integrity Problem 16 16
Patient-Device Incompatibility 16 16
Physical Resistance/Sticking 15 15
Device-Device Incompatibility 14 14
Device Markings/Labelling Problem 14 14
Device Reprocessing Problem 12 12
Degraded 11 11
Mechanics Altered 11 11
Corroded 10 10
Contamination /Decontamination Problem 9 9
Improper or Incorrect Procedure or Method 9 9
Use of Device Problem 8 8
Flaked 8 8
Inadequacy of Device Shape and/or Size 7 7
Failure to Align 7 7
Osseointegration Problem 7 7
Fitting Problem 6 6
Material Discolored 6 6
Separation Failure 5 5
Positioning Problem 5 5
No Apparent Adverse Event 5 5
Component Misassembled 5 5
Premature Separation 5 5
Packaging Problem 4 4
Failure to Disconnect 4 4
Device Damaged Prior to Use 4 4
Solder Joint Fracture 4 4
Tear, Rip or Hole in Device Packaging 4 4
Peeled/Delaminated 4 4
Misassembled 4 4
Nonstandard Device 3 3
Delivered as Unsterile Product 3 3
Off-Label Use 3 3
Shipping Damage or Problem 3 3
Difficult to Remove 3 3
Material Too Rigid or Stiff 3 3
Biocompatibility 3 3
Structural Problem 3 3
Material Split, Cut or Torn 3 3
Scratched Material 3 3
No Fail-Safe Mechanism 2 2
Device Contaminated During Manufacture or Shipping 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Device Fell 2 2
Device Damaged by Another Device 2 2
Activation, Positioning or Separation Problem 2 2
Device Slipped 2 2
Unexpected Therapeutic Results 2 2
Failure to Osseointegrate 2 2
Device Appears to Trigger Rejection 2 2
Unsealed Device Packaging 2 2
Material Erosion 2 2
Failure to Charge 2 2
Burst Container or Vessel 1 1
Complete Blockage 1 1
Disconnection 1 1
Failure to Disinfect 1 1
Material Disintegration 1 1
Entrapment of Device 1 1
Labelling, Instructions for Use or Training Problem 1 1
Incorrect Measurement 1 1
No Device Output 1 1
Migration or Expulsion of Device 1 1
Material Puncture/Hole 1 1
Device Difficult to Setup or Prepare 1 1
Residue After Decontamination 1 1
Suction Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2248 2248
Pain 345 345
No Known Impact Or Consequence To Patient 200 200
Unspecified Infection 183 183
No Consequences Or Impact To Patient 165 165
No Patient Involvement 164 164
Insufficient Information 152 152
No Information 150 150
Failure of Implant 150 150
No Code Available 130 130
Ambulation Difficulties 98 98
Loss of Range of Motion 67 67
Swelling/ Edema 67 67
Joint Laxity 63 63
Injury 60 60
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 35 35
Joint Dislocation 34 34
Bone Fracture(s) 31 31
Synovitis 27 27
Not Applicable 21 21
Foreign Body In Patient 20 20
Osteolysis 20 20
Swelling 17 17
Muscular Rigidity 16 16
Inadequate Osseointegration 15 15
Inflammation 14 14
Scar Tissue 13 13
Adhesion(s) 13 13
Fall 12 12
Hypersensitivity/Allergic reaction 12 12
Discomfort 12 12
Metal Related Pathology 10 10
Arthritis 10 10
Joint Disorder 9 9
Post Operative Wound Infection 8 8
Reaction 7 7
Limited Mobility Of The Implanted Joint 7 7
Device Embedded In Tissue or Plaque 7 7
Thrombosis/Thrombus 6 6
Fatigue 6 6
Hemorrhage/Bleeding 6 6
Ossification 6 6
Implant Pain 6 6
Unspecified Tissue Injury 5 5
Cyst(s) 5 5
Cellulitis 4 4
Laceration(s) 4 4
Fluid Discharge 4 4
Numbness 4 4
Subluxation 4 4
Unspecified Musculoskeletal problem 3 3
Arthralgia 3 3
Osteopenia/ Osteoporosis 3 3
Damage to Ligament(s) 3 3
Perforation 3 3
Pulmonary Embolism 3 3
Autoimmune Reaction 3 3
Bacterial Infection 3 3
Sepsis 2 2
Renal Failure 2 2
Muscle Weakness 2 2
Low Blood Pressure/ Hypotension 2 2
Fibrosis 2 2
Patient Problem/Medical Problem 2 2
Tissue Damage 2 2
Inadequate Pain Relief 2 2
Neck Stiffness 1 1
Burning Sensation 1 1
Deformity/ Disfigurement 1 1
Non-union Bone Fracture 1 1
Hip Fracture 1 1
Tissue Breakdown 1 1
Alteration In Body Temperature 1 1
Unspecified Immune System Problem 1 1
Hormonal Imbalance 1 1
Breast Discomfort/Pain 1 1
Muscle/Tendon Damage 1 1
Pocket Erosion 1 1
Necrosis 1 1
Erosion 1 1
Calcium Deposits/Calcification 1 1
Aspiration/Inhalation 1 1
Autoimmune Disorder 1 1
Syncope 1 1
Edema 1 1
Embolism 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 Biomet, Inc. II Dec-17-2020
4 Biomet, Inc. II May-28-2020
5 Exactech, Inc. II Oct-04-2021
6 MicroPort Orthopedics Inc. II Nov-22-2022
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