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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 351 351

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1259 1259
Insufficient Information 549 549
Adverse Event Without Identified Device or Use Problem 360 360
Naturally Worn 237 237
Loosening of Implant Not Related to Bone-Ingrowth 184 184
Loose or Intermittent Connection 154 154
Unstable 141 141
Crack 136 136
Appropriate Term/Code Not Available 123 123
Fracture 111 111
Device Dislodged or Dislocated 100 100
Connection Problem 66 66
Material Deformation 56 56
Detachment of Device or Device Component 55 55
Migration or Expulsion of Device 50 50
Loss of Osseointegration 46 46
Mechanical Problem 40 40
Defective Device 39 39
Component Missing 39 39
Dull, Blunt 37 37
Loss of or Failure to Bond 37 37
Mechanical Jam 36 36
Difficult to Insert 35 35
Material Fragmentation 32 32
Malposition of Device 30 30
Material Separation 27 27
Patient Device Interaction Problem 27 27
Incomplete or Inadequate Connection 22 22
Device Contamination with Chemical or Other Material 21 21
Noise, Audible 20 20
Material Twisted/Bent 20 20
Migration 19 19
Unintended Movement 19 19
Device-Device Incompatibility 17 17
Material Integrity Problem 16 16
Patient-Device Incompatibility 16 16
Device Markings/Labelling Problem 14 14
Physical Resistance/Sticking 13 13
Device Reprocessing Problem 12 12
Fitting Problem 11 11
Use of Device Problem 10 10
Failure to Align 9 9
Contamination /Decontamination Problem 9 9
Mechanics Altered 9 9
Osseointegration Problem 8 8
Inadequacy of Device Shape and/or Size 7 7
Improper or Incorrect Procedure or Method 7 7
Material Discolored 7 7
Tear, Rip or Hole in Device Packaging 6 6
Positioning Problem 6 6
Scratched Material 6 6
No Apparent Adverse Event 5 5
Packaging Problem 5 5
Device Damaged Prior to Use 5 5
Corroded 5 5
Detachment Of Device Component 5 5
Positioning Failure 5 5
Flaked 5 5
Misassembled 4 4
Failure to Disconnect 4 4
Separation Failure 3 3
Structural Problem 3 3
Device Operates Differently Than Expected 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Premature Separation 3 3
Material Split, Cut or Torn 3 3
Delivered as Unsterile Product 3 3
Material Erosion 3 3
Biocompatibility 3 3
Shipping Damage or Problem 3 3
Peeled/Delaminated 3 3
Off-Label Use 3 3
Difficult to Remove 3 3
Material Too Rigid or Stiff 2 2
Unsealed Device Packaging 2 2
Device Appears to Trigger Rejection 2 2
Disassembly 2 2
Misconnection 2 2
Nonstandard Device 2 2
Component Falling 2 2
Partial Blockage 2 2
Failure to Charge 2 2
Separation Problem 2 2
Device Fell 2 2
No Fail-Safe Mechanism 2 2
Device Packaging Compromised 2 2
Activation, Positioning or SeparationProblem 2 2
Device Contaminated During Manufacture or Shipping 2 2
Material Distortion 1 1
Device Damaged by Another Device 1 1
Moisture or Humidity Problem 1 1
Torn Material 1 1
Programming Issue 1 1
Audible Prompt/Feedback Problem 1 1
Sharp Edges 1 1
Component Misassembled 1 1
Misassembly During Maintenance/Repair 1 1
Thickening of Material 1 1
Degraded 1 1
Difficult or Delayed Positioning 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1519 1519
No Information 498 498
Pain 495 495
No Known Impact Or Consequence To Patient 243 243
Unspecified Infection 240 240
No Consequences Or Impact To Patient 221 221
No Code Available 219 219
No Patient Involvement 169 169
Failure of Implant 108 108
Ambulation Difficulties 100 100
Injury 100 100
Insufficient Information 90 90
Joint Dislocation 69 69
Bone Fracture(s) 63 63
Swelling/ Edema 62 62
Joint Laxity 58 58
Loss of Range of Motion 56 56
Osteolysis 54 54
Not Applicable 54 54
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 34 34
Swelling 34 34
Synovitis 24 24
Foreign Body In Patient 21 21
Inadequate Osseointegration 16 16
Discomfort 15 15
Muscular Rigidity 15 15
Fall 14 14
Hemorrhage/Bleeding 13 13
Limited Mobility Of The Implanted Joint 13 13
Joint Disorder 12 12
Hypersensitivity/Allergic reaction 12 12
Adhesion(s) 12 12
Arthritis 11 11
Post Operative Wound Infection 11 11
Reaction 11 11
Death 9 9
Inflammation 9 9
Neck Stiffness 8 8
Scar Tissue 6 6
Thrombosis 6 6
Fatigue 6 6
Cellulitis 6 6
Pulmonary Embolism 5 5
Device Embedded In Tissue or Plaque 5 5
Implant Pain 5 5
Unspecified Tissue Injury 4 4
Metal Related Pathology 4 4
Thrombosis/Thrombus 4 4
Numbness 4 4
Joint Swelling 4 4
Cyst(s) 4 4
Damage to Ligament(s) 4 4
Laceration(s) 3 3
Hematoma 3 3
Autoimmune Reaction 3 3
Bacterial Infection 3 3
Foreign Body Reaction 3 3
Ossification 3 3
Tissue Damage 3 3
Urinary Tract Infection 3 3
Burning Sensation 3 3
Sepsis 3 3
Patient Problem/Medical Problem 3 3
Unspecified Musculoskeletal problem 3 3
Vascular Dissection 2 2
Edema 2 2
High Blood Pressure/ Hypertension 2 2
Low Blood Pressure/ Hypotension 2 2
Rash 2 2
Renal Failure 2 2
Phlebitis 1 1
Muscle Weakness 1 1
Irritation 1 1
Embolism 1 1
Host-Tissue Reaction 1 1
Syncope 1 1
Aspiration/Inhalation 1 1
Autoimmune Disorder 1 1
Fibrosis 1 1
Tissue Breakdown 1 1
Alteration In Body Temperature 1 1
Osteopenia/ Osteoporosis 1 1
Scarring 1 1
Deformity/ Disfigurement 1 1
Non-union Bone Fracture 1 1
Muscle/Tendon Damage 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 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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