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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
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
2017 402 402
2018 613 613
2019 367 367
2020 1055 1055
2021 1222 1222
2022 653 653

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1401 1401
Insufficient Information 549 549
Adverse Event Without Identified Device or Use Problem 373 373
Naturally Worn 243 243
Fracture 195 195
Loosening of Implant Not Related to Bone-Ingrowth 192 192
Loose or Intermittent Connection 154 154
Unstable 144 144
Crack 140 140
Appropriate Term/Code Not Available 131 131
Device Dislodged or Dislocated 101 101
Detachment of Device or Device Component 81 81
Connection Problem 66 66
Material Deformation 65 65
Loss of Osseointegration 50 50
Migration or Expulsion of Device 50 50
Mechanical Problem 40 40
Component Missing 40 40
Defective Device 39 39
Loss of or Failure to Bond 38 38
Dull, Blunt 37 37
Mechanical Jam 36 36
Difficult to Insert 35 35
Material Fragmentation 33 33
Patient Device Interaction Problem 30 30
Malposition of Device 30 30
Material Separation 27 27
Migration 26 26
Noise, Audible 23 23
Incomplete or Inadequate Connection 22 22
Unintended Movement 21 21
Device Contamination with Chemical or Other Material 21 21
Material Twisted/Bent 21 21
Device-Device Incompatibility 17 17
Material Integrity Problem 16 16
Patient-Device Incompatibility 16 16
Physical Resistance/Sticking 14 14
Device Markings/Labelling Problem 14 14
Device Reprocessing Problem 12 12
Fitting Problem 11 11
Mechanics Altered 11 11
Use of Device Problem 10 10
Corroded 10 10
Failure to Align 9 9
Contamination /Decontamination Problem 9 9
Inadequacy of Device Shape and/or Size 8 8
Osseointegration Problem 8 8
Improper or Incorrect Procedure or Method 7 7
Material Discolored 7 7
Tear, Rip or Hole in Device Packaging 6 6
Positioning Failure 6 6
Positioning Problem 6 6
Scratched Material 6 6
Premature Separation 5 5
Device Damaged Prior to Use 5 5
Flaked 5 5
No Apparent Adverse Event 5 5
Packaging Problem 5 5
Degraded 5 5
Detachment Of Device Component 5 5
Peeled/Delaminated 4 4
Misassembled 4 4
Failure to Disconnect 4 4
Biocompatibility 3 3
Delivered as Unsterile Product 3 3
Material Erosion 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Shipping Damage or Problem 3 3
Material Split, Cut or Torn 3 3
Structural Problem 3 3
Device Operates Differently Than Expected 3 3
Off-Label Use 3 3
Difficult to Remove 3 3
Separation Failure 3 3
Material Too Rigid or Stiff 2 2
Failure to Osseointegrate 2 2
Device Damaged by Another Device 2 2
Device Packaging Compromised 2 2
Unsealed Device Packaging 2 2
Partial Blockage 2 2
Device Appears to Trigger Rejection 2 2
Misconnection 2 2
Device Fell 2 2
Device Contaminated During Manufacture or Shipping 2 2
Activation, Positioning or SeparationProblem 2 2
No Fail-Safe Mechanism 2 2
Separation Problem 2 2
Device Slipped 2 2
Failure to Charge 2 2
Disassembly 2 2
Nonstandard Device 2 2
Component Falling 2 2
Entrapment of Device 2 2
Thermal Decomposition of Device 1 1
Difficult or Delayed Positioning 1 1
Disconnection 1 1
Residue After Decontamination 1 1
Material Distortion 1 1
Component Misassembled 1 1
Sharp Edges 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1771 1771
Pain 509 509
No Information 498 498
Unspecified Infection 243 243
No Known Impact Or Consequence To Patient 243 243
No Consequences Or Impact To Patient 221 221
No Code Available 219 219
No Patient Involvement 169 169
Failure of Implant 121 121
Insufficient Information 104 104
Ambulation Difficulties 103 103
Injury 100 100
Joint Dislocation 71 71
Bone Fracture(s) 65 65
Swelling/ Edema 63 63
Loss of Range of Motion 60 60
Joint Laxity 59 59
Osteolysis 56 56
Not Applicable 54 54
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 34 34
Swelling 34 34
Synovitis 25 25
Foreign Body In Patient 22 22
Inadequate Osseointegration 16 16
Discomfort 16 16
Muscular Rigidity 15 15
Hypersensitivity/Allergic reaction 15 15
Fall 15 15
Hemorrhage/Bleeding 13 13
Limited Mobility Of The Implanted Joint 13 13
Joint Disorder 12 12
Adhesion(s) 12 12
Arthritis 11 11
Post Operative Wound Infection 11 11
Reaction 11 11
Scar Tissue 9 9
Death 9 9
Inflammation 9 9
Neck Stiffness 8 8
Device Embedded In Tissue or Plaque 6 6
Thrombosis 6 6
Fatigue 6 6
Cellulitis 6 6
Pulmonary Embolism 5 5
Implant Pain 5 5
Metal Related Pathology 5 5
Thrombosis/Thrombus 4 4
Unspecified Tissue Injury 4 4
Cyst(s) 4 4
Damage to Ligament(s) 4 4
Numbness 4 4
Joint Swelling 4 4
Osteopenia/ Osteoporosis 3 3
Patient Problem/Medical Problem 3 3
Tissue Damage 3 3
Urinary Tract Infection 3 3
Burning Sensation 3 3
Laceration(s) 3 3
Sepsis 3 3
Hematoma 3 3
Autoimmune Reaction 3 3
Bacterial Infection 3 3
Foreign Body Reaction 3 3
Ossification 3 3
Unspecified Musculoskeletal problem 3 3
Edema 2 2
High Blood Pressure/ Hypertension 2 2
Low Blood Pressure/ Hypotension 2 2
Rash 2 2
Renal Failure 2 2
Vascular Dissection 2 2
Fibrosis 1 1
Tissue Breakdown 1 1
Alteration In Body Temperature 1 1
Deformity/ Disfigurement 1 1
Non-union Bone Fracture 1 1
Scarring 1 1
Hip Fracture 1 1
Phlebitis 1 1
Muscle Weakness 1 1
Necrosis 1 1
Irritation 1 1
Embolism 1 1
Calcium Deposits/Calcification 1 1
Host-Tissue Reaction 1 1
Syncope 1 1
Aspiration/Inhalation 1 1
Autoimmune Disorder 1 1
Muscle/Tendon Damage 1 1
Breast Discomfort/Pain 1 1
Subluxation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Aesculap Implant Systems LLC II Sep-22-2021
2 Biomet, Inc. II Dec-17-2020
3 Biomet, Inc. II May-28-2020
4 DePuy Orthopaedics, Inc. II Mar-20-2018
5 Exactech, Inc. II Oct-04-2021
6 Zimmer Biomet, Inc. II Mar-27-2017
7 Zimmer Biomet, Inc. II Jan-06-2017
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