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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 612 612
2019 367 367
2020 1055 1055
2021 1219 1219
2022 842 842
2023 401 401
2024 125 125

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1481 1481
Insufficient Information 614 614
Fracture 531 531
Adverse Event Without Identified Device or Use Problem 427 427
Naturally Worn 262 262
Loosening of Implant Not Related to Bone-Ingrowth 209 209
Unstable 166 166
Loose or Intermittent Connection 154 154
Crack 146 146
Appropriate Term/Code Not Available 135 135
Detachment of Device or Device Component 132 132
Device Dislodged or Dislocated 106 106
Material Deformation 70 70
Connection Problem 66 66
Loss of Osseointegration 59 59
Migration or Expulsion of Device 50 50
Positioning Failure 44 44
Material Fragmentation 43 43
Component Missing 41 41
Mechanical Problem 40 40
Defective Device 39 39
Mechanical Jam 39 39
Loss of or Failure to Bond 38 38
Dull, Blunt 37 37
Difficult to Insert 36 36
Malposition of Device 34 34
Migration 29 29
Material Separation 28 28
Noise, Audible 26 26
Patient Device Interaction Problem 25 25
Incomplete or Inadequate Connection 22 22
Material Twisted/Bent 22 22
Device Contamination with Chemical or Other Material 21 21
Unintended Movement 21 21
Material Integrity Problem 17 17
Device-Device Incompatibility 17 17
Patient-Device Incompatibility 16 16
Physical Resistance/Sticking 15 15
Device Markings/Labelling Problem 14 14
Mechanics Altered 12 12
Device Reprocessing Problem 12 12
Degraded 11 11
Use of Device Problem 11 11
Fitting Problem 11 11
Corroded 10 10
Improper or Incorrect Procedure or Method 9 9
Failure to Align 9 9
Separation Failure 9 9
Contamination /Decontamination Problem 9 9
Osseointegration Problem 8 8
Inadequacy of Device Shape and/or Size 8 8
Flaked 8 8
Material Discolored 7 7
Tear, Rip or Hole in Device Packaging 7 7
Packaging Problem 7 7
Positioning Problem 7 7
Scratched Material 6 6
No Apparent Adverse Event 5 5
Premature Separation 5 5
Component Misassembled 5 5
Device Damaged Prior to Use 5 5
Detachment Of Device Component 5 5
Misassembled 4 4
Solder Joint Fracture 4 4
Failure to Disconnect 4 4
Peeled/Delaminated 4 4
Off-Label Use 4 4
Difficult to Remove 3 3
Material Too Rigid or Stiff 3 3
Nonstandard Device 3 3
Delivered as Unsterile Product 3 3
Shipping Damage or Problem 3 3
Structural Problem 3 3
Material Erosion 3 3
Material Split, Cut or Torn 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Biocompatibility 3 3
Device Operates Differently Than Expected 3 3
Device Damaged by Another Device 2 2
Device Packaging Compromised 2 2
Device Contaminated During Manufacture or Shipping 2 2
Activation, Positioning or Separation Problem 2 2
No Fail-Safe Mechanism 2 2
Device Fell 2 2
Separation Problem 2 2
Difficult or Delayed Separation 2 2
Entrapment of Device 2 2
Disassembly 2 2
Misconnection 2 2
Component Falling 2 2
Failure to Charge 2 2
Failure to Osseointegrate 2 2
Device Slipped 2 2
Unsealed Device Packaging 2 2
Unexpected Therapeutic Results 2 2
Material Puncture/Hole 2 2
Device Appears to Trigger Rejection 2 2
No Device Output 1 1
Difficult To Position 1 1
Device Difficult to Setup or Prepare 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2280 2280
Pain 552 552
No Information 498 498
Unspecified Infection 293 293
No Known Impact Or Consequence To Patient 242 242
No Consequences Or Impact To Patient 221 221
No Code Available 219 219
No Patient Involvement 169 169
Failure of Implant 158 158
Insufficient Information 157 157
Ambulation Difficulties 105 105
Injury 100 100
Loss of Range of Motion 80 80
Joint Dislocation 74 74
Swelling/ Edema 70 70
Bone Fracture(s) 68 68
Joint Laxity 63 63
Osteolysis 59 59
Not Applicable 54 54
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 36 36
Swelling 34 34
Synovitis 28 28
Foreign Body In Patient 24 24
Inadequate Osseointegration 21 21
Discomfort 17 17
Fall 16 16
Muscular Rigidity 16 16
Post Operative Wound Infection 15 15
Scar Tissue 14 14
Inflammation 14 14
Hemorrhage/Bleeding 13 13
Adhesion(s) 13 13
Limited Mobility Of The Implanted Joint 13 13
Joint Disorder 12 12
Arthritis 12 12
Hypersensitivity/Allergic reaction 12 12
Reaction 11 11
Metal Related Pathology 10 10
Death 9 9
Neck Stiffness 8 8
Device Embedded In Tissue or Plaque 7 7
Thrombosis/Thrombus 6 6
Implant Pain 6 6
Thrombosis 6 6
Cellulitis 6 6
Ossification 6 6
Fatigue 6 6
Laceration(s) 5 5
Pulmonary Embolism 5 5
Cyst(s) 5 5
Osteopenia/ Osteoporosis 5 5
Unspecified Tissue Injury 5 5
Subluxation 4 4
Fluid Discharge 4 4
Numbness 4 4
Joint Swelling 4 4
Damage to Ligament(s) 4 4
Foreign Body Reaction 4 4
Hematoma 3 3
Autoimmune Reaction 3 3
Bacterial Infection 3 3
Sepsis 3 3
Arthralgia 3 3
Tissue Damage 3 3
Urinary Tract Infection 3 3
Burning Sensation 3 3
Perforation 3 3
Fibrosis 3 3
Patient Problem/Medical Problem 3 3
Unspecified Musculoskeletal problem 3 3
Vascular Dissection 2 2
Rash 2 2
Renal Failure 2 2
Inadequate Pain Relief 2 2
Edema 2 2
High Blood Pressure/ Hypertension 2 2
Low Blood Pressure/ Hypotension 2 2
Muscle Weakness 2 2
Necrosis 1 1
Irritation 1 1
Host-Tissue Reaction 1 1
Embolism 1 1
Erosion 1 1
Calcium Deposits/Calcification 1 1
Syncope 1 1
Abdominal Pain 1 1
Abrasion 1 1
Aspiration/Inhalation 1 1
Autoimmune Disorder 1 1
Deformity/ Disfigurement 1 1
Non-union Bone Fracture 1 1
Tissue Breakdown 1 1
Alteration In Body Temperature 1 1
Scarring 1 1
Phlebitis 1 1
Pocket Erosion 1 1
Hip Fracture 1 1
Muscle/Tendon Damage 1 1
Hormonal Imbalance 1 1
Breast Discomfort/Pain 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 DePuy Orthopaedics, Inc. II Mar-20-2018
6 Exactech, Inc. II Oct-04-2021
7 MicroPort Orthopedics Inc. II Nov-22-2022
8 Zimmer Biomet, Inc. II Mar-27-2017
9 Zimmer Biomet, Inc. II Jan-06-2017
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