• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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
2018 613 613
2019 367 367
2020 1055 1055
2021 1222 1222
2022 850 850

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1416 1416
Insufficient Information 377 377
Adverse Event Without Identified Device or Use Problem 373 373
Fracture 296 296
Loosening of Implant Not Related to Bone-Ingrowth 193 193
Naturally Worn 168 168
Crack 139 139
Loose or Intermittent Connection 132 132
Unstable 132 132
Appropriate Term/Code Not Available 120 120
Detachment of Device or Device Component 90 90
Device Dislodged or Dislocated 79 79
Material Deformation 68 68
Connection Problem 66 66
Loss of Osseointegration 51 51
Component Missing 41 41
Mechanical Problem 40 40
Material Fragmentation 39 39
Defective Device 39 39
Dull, Blunt 37 37
Mechanical Jam 36 36
Difficult to Insert 35 35
Migration or Expulsion of Device 30 30
Patient Device Interaction Problem 29 29
Loss of or Failure to Bond 28 28
Material Separation 28 28
Malposition of Device 27 27
Migration 26 26
Incomplete or Inadequate Connection 22 22
Noise, Audible 22 22
Unintended Movement 21 21
Material Twisted/Bent 21 21
Device Contamination with Chemical or Other Material 21 21
Device-Device Incompatibility 17 17
Material Integrity Problem 16 16
Patient-Device Incompatibility 16 16
Device Markings/Labelling Problem 14 14
Physical Resistance/Sticking 14 14
Device Reprocessing Problem 12 12
Corroded 10 10
Fitting Problem 10 10
Use of Device Problem 10 10
Mechanics Altered 10 10
Contamination /Decontamination Problem 9 9
Degraded 9 9
Positioning Failure 8 8
Flaked 8 8
Inadequacy of Device Shape and/or Size 8 8
Improper or Incorrect Procedure or Method 7 7
Failure to Align 7 7
Osseointegration Problem 7 7
Packaging Problem 6 6
Tear, Rip or Hole in Device Packaging 6 6
Material Discolored 6 6
No Apparent Adverse Event 5 5
Separation Failure 5 5
Premature Separation 5 5
Failure to Disconnect 4 4
Positioning Problem 4 4
Misassembled 4 4
Device Damaged Prior to Use 4 4
Peeled/Delaminated 4 4
Off-Label Use 4 4
Difficult to Remove 3 3
Material Too Rigid or Stiff 3 3
Shipping Damage or Problem 3 3
Biocompatibility 3 3
Structural Problem 3 3
Delivered as Unsterile Product 3 3
Scratched Material 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Material Split, Cut or Torn 3 3
Device Fell 2 2
Separation Problem 2 2
No Fail-Safe Mechanism 2 2
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
Nonstandard Device 2 2
Material Erosion 2 2
Failure to Charge 2 2
Partial Blockage 2 2
Failure to Osseointegrate 2 2
Device Slipped 2 2
Unexpected Therapeutic Results 2 2
Unsealed Device Packaging 2 2
Device Appears to Trigger Rejection 2 2
Material Puncture/Hole 1 1
Product Quality Problem 1 1
Difficult To Position 1 1
Device Difficult to Setup or Prepare 1 1
Suction Problem 1 1
Metal Shedding Debris 1 1
Defective Component 1 1
Solder Joint Fracture 1 1
Residue After Decontamination 1 1
Device Issue 1 1
Failure to Calibrate 1 1
Deformation Due to Compressive Stress 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1937 1937
Pain 439 439
No Information 339 339
No Known Impact Or Consequence To Patient 229 229
Unspecified Infection 213 213
No Consequences Or Impact To Patient 201 201
No Code Available 192 192
No Patient Involvement 169 169
Failure of Implant 123 123
Insufficient Information 109 109
Ambulation Difficulties 101 101
Injury 86 86
Swelling/ Edema 66 66
Joint Laxity 61 61
Loss of Range of Motion 61 61
Joint Dislocation 56 56
Not Applicable 54 54
Bone Fracture(s) 53 53
Osteolysis 35 35
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 35 35
Swelling 27 27
Synovitis 24 24
Foreign Body In Patient 21 21
Muscular Rigidity 16 16
Hypersensitivity/Allergic reaction 15 15
Inadequate Osseointegration 15 15
Inflammation 14 14
Fall 14 14
Discomfort 13 13
Adhesion(s) 12 12
Arthritis 10 10
Reaction 10 10
Post Operative Wound Infection 10 10
Joint Disorder 10 10
Limited Mobility Of The Implanted Joint 10 10
Scar Tissue 9 9
Device Embedded In Tissue or Plaque 7 7
Neck Stiffness 7 7
Death 7 7
Fatigue 6 6
Cellulitis 6 6
Hemorrhage/Bleeding 6 6
Cyst(s) 5 5
Implant Pain 5 5
Metal Related Pathology 5 5
Unspecified Tissue Injury 4 4
Fluid Discharge 4 4
Thrombosis/Thrombus 4 4
Damage to Ligament(s) 4 4
Numbness 4 4
Tissue Damage 3 3
Urinary Tract Infection 3 3
Burning Sensation 3 3
Joint Swelling 3 3
Osteopenia/ Osteoporosis 3 3
Hematoma 3 3
Laceration(s) 3 3
Ossification 3 3
Pulmonary Embolism 3 3
Autoimmune Reaction 3 3
Bacterial Infection 3 3
Unspecified Musculoskeletal problem 3 3
High Blood Pressure/ Hypertension 2 2
Low Blood Pressure/ Hypotension 2 2
Rash 2 2
Renal Failure 2 2
Patient Problem/Medical Problem 2 2
Sepsis 2 2
Scarring 1 1
Hip Fracture 1 1
Tissue Breakdown 1 1
Alteration In Body Temperature 1 1
Fibrosis 1 1
Vascular Dissection 1 1
Deformity/ Disfigurement 1 1
Non-union Bone Fracture 1 1
Perforation 1 1
Phlebitis 1 1
Muscle Weakness 1 1
Necrosis 1 1
Host-Tissue Reaction 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
Muscle/Tendon Damage 1 1
Hormonal Imbalance 1 1
Breast Discomfort/Pain 1 1
Subluxation 1 1
Unspecified Immune System Problem 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
-
-