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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


Premarket Reviews
ManufacturerDecision
DEPUY IRELAND UC
  SUBSTANTIALLY EQUIVALENT 1
MICROPORT ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
NANOORTHO, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 343 343
2017 402 402
2018 613 613
2019 367 367
2020 1055 1055
2021 1024 1024

Device Problems MDRs with this Device Problem Events in those MDRs
Break 921 921
Insufficient Information 640 640
Naturally Worn 364 364
Adverse Event Without Identified Device or Use Problem 329 329
Loosening of Implant Not Related to Bone-Ingrowth 183 183
Loose or Intermittent Connection 168 168
Unstable 149 149
Appropriate Term/Code Not Available 127 127
Device Dislodged or Dislocated 112 112
Crack 93 93
Fracture 86 86
Connection Problem 64 64
Migration or Expulsion of Device 54 54
Material Deformation 53 53
Loss of Osseointegration 44 44
Loss of or Failure to Bond 44 44
Component Missing 38 38
Defective Device 37 37
Dull, Blunt 37 37
Malposition of Device 34 34
Mechanical Problem 34 34
Mechanical Jam 34 34
Difficult to Insert 33 33
Detachment of Device or Device Component 29 29
Material Separation 26 26
Material Fragmentation 23 23
Patient Device Interaction Problem 23 23
Incomplete or Inadequate Connection 22 22
Noise, Audible 22 22
Device Contamination with Chemical or Other Material 21 21
Migration 19 19
Material Twisted/Bent 18 18
Device-Device Incompatibility 17 17
Device Markings/Labelling Problem 16 16
Patient-Device Incompatibility 14 14
Fitting Problem 13 13
Unintended Movement 12 12
Device Reprocessing Problem 12 12
Material Integrity Problem 12 12
Physical Resistance/Sticking 11 11
Positioning Problem 10 10
Use of Device Problem 10 10
Contamination /Decontamination Problem 9 9
Osseointegration Problem 8 8
Improper or Incorrect Procedure or Method 7 7
Failure to Align 7 7
Inadequacy of Device Shape and/or Size 7 7
Tear, Rip or Hole in Device Packaging 6 6
Material Discolored 6 6
Device Operates Differently Than Expected 6 6
Disassembly 6 6
Corroded 5 5
Detachment Of Device Component 5 5
Packaging Problem 5 5
Scratched Material 5 5
Flaked 5 5
Device Damaged Prior to Use 5 5
Material Erosion 4 4
Mechanics Altered 4 4
Failure to Disconnect 4 4
No Apparent Adverse Event 4 4
Structural Problem 3 3
Misassembled 3 3
Difficult to Remove 3 3
Biocompatibility 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Device Slipped 3 3
Peeled/Delaminated 3 3
Off-Label Use 3 3
Material Too Rigid or Stiff 2 2
Separation Failure 2 2
Unsealed Device Packaging 2 2
Device Packaging Compromised 2 2
Partial Blockage 2 2
Device Contaminated During Manufacture or Shipping 2 2
No Fail-Safe Mechanism 2 2
Separation Problem 2 2
Component Falling 2 2
Device Fell 2 2
Misconnection 2 2
Device Appears to Trigger Rejection 2 2
Delivered as Unsterile Product 2 2
Shipping Damage or Problem 2 2
Material Split, Cut or Torn 2 2
Failure to Charge 2 2
Degraded 2 2
Metal Shedding Debris 1 1
Suction Problem 1 1
Incorrect Measurement 1 1
Device Difficult to Setup or Prepare 1 1
Material Puncture/Hole 1 1
Failure to Calibrate 1 1
Residue After Decontamination 1 1
Difficult or Delayed Positioning 1 1
Component Misassembled 1 1
Failure To Adhere Or Bond 1 1
Contamination 1 1
Compatibility Problem 1 1
Defective Component 1 1
Failure to Osseointegrate 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1064 1064
No Information 621 621
Pain 580 580
No Known Impact Or Consequence To Patient 273 273
Unspecified Infection 264 264
No Code Available 232 232
No Consequences Or Impact To Patient 223 223
No Patient Involvement 170 170
Injury 119 119
Ambulation Difficulties 101 101
Osteolysis 95 95
Failure of Implant 94 94
Bone Fracture(s) 68 68
Joint Dislocation 65 65
Swelling/ Edema 61 61
Insufficient Information 61 61
Joint Laxity 57 57
Not Applicable 55 55
Loss of Range of Motion 54 54
Swelling 36 36
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 31 31
Synovitis 24 24
Foreign Body In Patient 18 18
Discomfort 16 16
Fall 16 16
Joint Disorder 16 16
Muscular Rigidity 15 15
Inadequate Osseointegration 15 15
Reaction 14 14
Limited Mobility Of The Implanted Joint 14 14
Hemorrhage/Bleeding 13 13
Post Operative Wound Infection 11 11
Adhesion(s) 11 11
Neck Stiffness 10 10
Arthritis 10 10
Inflammation 10 10
Death 9 9
Cellulitis 6 6
Thrombosis 6 6
Scar Tissue 6 6
Hypersensitivity/Allergic reaction 6 6
Damage to Ligament(s) 5 5
Device Embedded In Tissue or Plaque 5 5
Pulmonary Embolism 5 5
Implant Pain 5 5
Unspecified Tissue Injury 4 4
Tissue Damage 4 4
Foreign Body Reaction 4 4
Cyst(s) 4 4
Thrombosis/Thrombus 4 4
Fatigue 4 4
Metal Related Pathology 4 4
Numbness 4 4
Joint Swelling 4 4
Patient Problem/Medical Problem 3 3
Urinary Tract Infection 3 3
Bacterial Infection 3 3
Hematoma 3 3
Autoimmune Reaction 3 3
Sepsis 3 3
Burning Sensation 3 3
Laceration(s) 2 2
Vascular Dissection 2 2
High Blood Pressure/ Hypertension 2 2
Rash 2 2
Low Blood Pressure/ Hypotension 2 2
Renal Failure 2 2
Edema 2 2
Non-union Bone Fracture 1 1
Irritation 1 1
Host-Tissue Reaction 1 1
Osteopenia/ Osteoporosis 1 1
Embolism 1 1
Scarring 1 1
Muscle/Tendon Damage 1 1
Deformity/ Disfigurement 1 1
Muscle Weakness 1 1
Ossification 1 1
Syncope 1 1
Tissue Breakdown 1 1
Alteration In Body Temperature 1 1
Fibrosis 1 1
Breast Discomfort/Pain 1 1
Unspecified Musculoskeletal problem 1 1
Aspiration/Inhalation 1 1
Autoimmune Disorder 1 1
Phlebitis 1 1
Arthralgia 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 Zimmer Biomet, Inc. II Mar-27-2017
6 Zimmer Biomet, Inc. II Jan-06-2017
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