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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
AESCULAP IMPLANT SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 1
BIOMET MANUFACTURING CORP.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET UK LTD.
  SUBSTANTIALLY EQUIVALENT 1
DEPUY IRELAND UC
  SUBSTANTIALLY EQUIVALENT 1
MAKO SURGICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MATERIALISE N.V.
  SUBSTANTIALLY EQUIVALENT 1
MICROPORT ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
NANOORTHO, LLC
  SUBSTANTIALLY EQUIVALENT 1
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 305 305
2015 344 344
2016 343 343
2017 402 402
2018 612 612
2019 367 367
2020 1055 1055
2021 1219 1219
2022 842 842
2023 401 401
2024 161 161

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1514 1514
Insufficient Information 872 872
Naturally Worn 642 642
Fracture 560 560
Adverse Event Without Identified Device or Use Problem 465 465
Loose or Intermittent Connection 213 213
Loosening of Implant Not Related to Bone-Ingrowth 212 212
Unstable 195 195
Appropriate Term/Code Not Available 168 168
Device Dislodged or Dislocated 161 161
Crack 149 149
Detachment of Device or Device Component 141 141
Loss of or Failure to Bond 74 74
Material Deformation 73 73
Loss of Osseointegration 70 70
Connection Problem 68 68
Migration or Expulsion of Device 60 60
Malposition of Device 52 52
Difficult to Insert 49 49
Positioning Failure 47 47
Material Fragmentation 45 45
Mechanical Problem 43 43
Component Missing 42 42
Defective Device 39 39
Mechanical Jam 39 39
Dull, Blunt 37 37
Noise, Audible 32 32
Migration 29 29
Material Separation 28 28
Patient Device Interaction Problem 25 25
Material Integrity Problem 24 24
Failure to Align 23 23
Material Twisted/Bent 22 22
Device Contamination with Chemical or Other Material 22 22
Unintended Movement 22 22
Incomplete or Inadequate Connection 22 22
Device Slipped 21 21
Patient-Device Incompatibility 18 18
Device-Device Incompatibility 17 17
Device Markings/Labelling Problem 16 16
Fitting Problem 16 16
Device Contaminated During Manufacture or Shipping 15 15
Physical Resistance/Sticking 15 15
Positioning Problem 14 14
Mechanics Altered 12 12
Degraded 12 12
Device Reprocessing Problem 12 12
Use of Device Problem 11 11
Corroded 10 10
Device Operates Differently Than Expected 10 10
Separation Failure 10 10
Contamination /Decontamination Problem 9 9
Scratched Material 9 9
Disassembly 9 9
Inadequacy of Device Shape and/or Size 9 9
Improper or Incorrect Procedure or Method 9 9
Material Too Rigid or Stiff 8 8
Material Discolored 8 8
Flaked 8 8
Osseointegration Problem 8 8
Packaging Problem 7 7
Tear, Rip or Hole in Device Packaging 7 7
No Apparent Adverse Event 6 6
Component Misassembled 5 5
Premature Separation 5 5
Device Damaged Prior to Use 5 5
Detachment Of Device Component 5 5
Material Erosion 4 4
Misassembled 4 4
Solder Joint Fracture 4 4
Peeled/Delaminated 4 4
Off-Label Use 4 4
Device Packaging Compromised 4 4
Failure to Disconnect 4 4
Structural Problem 3 3
Biocompatibility 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Material Distortion 3 3
Material Split, Cut or Torn 3 3
Difficult to Remove 3 3
Nonstandard Device 3 3
Delivered as Unsterile Product 3 3
Shipping Damage or Problem 3 3
Metal Shedding Debris 3 3
Sticking 3 3
Device Abrasion From Instrument Or Another Object 3 3
Failure To Adhere Or Bond 3 3
Failure to Charge 2 2
Component Falling 2 2
Misconnection 2 2
Labelling, Instructions for Use or Training Problem 2 2
Entrapment of Device 2 2
Unexpected Therapeutic Results 2 2
Failure to Osseointegrate 2 2
Unsealed Device Packaging 2 2
Material Puncture/Hole 2 2
Device Appears to Trigger Rejection 2 2
Separation Problem 2 2
Difficult or Delayed Separation 2 2
Device Fell 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2311 2311
No Information 865 865
Pain 832 832
Unspecified Infection 367 367
No Known Impact Or Consequence To Patient 307 307
No Code Available 306 306
No Consequences Or Impact To Patient 230 230
Osteolysis 187 187
No Patient Involvement 170 170
Failure of Implant 160 160
Insufficient Information 159 159
Injury 131 131
Ambulation Difficulties 110 110
Bone Fracture(s) 90 90
Loss of Range of Motion 85 85
Joint Dislocation 79 79
Swelling/ Edema 70 70
Joint Laxity 63 63
Not Applicable 55 55
Swelling 38 38
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 36 36
Synovitis 29 29
Fall 25 25
Foreign Body In Patient 25 25
Discomfort 24 24
Inadequate Osseointegration 22 22
Muscular Rigidity 18 18
Arthritis 17 17
Reaction 17 17
Joint Disorder 16 16
Inflammation 16 16
Post Operative Wound Infection 16 16
Limited Mobility Of The Implanted Joint 16 16
Scar Tissue 15 15
Hypersensitivity/Allergic reaction 14 14
Hemorrhage/Bleeding 13 13
Adhesion(s) 13 13
Neck Stiffness 11 11
Death 10 10
Metal Related Pathology 10 10
Device Embedded In Tissue or Plaque 7 7
Thrombosis 7 7
Joint Swelling 6 6
Fatigue 6 6
Foreign Body Reaction 6 6
Laceration(s) 6 6
Cellulitis 6 6
Ossification 6 6
Thrombosis/Thrombus 6 6
Implant Pain 6 6
Unspecified Tissue Injury 5 5
Osteopenia/ Osteoporosis 5 5
Pulmonary Embolism 5 5
Cyst(s) 5 5
Damage to Ligament(s) 5 5
Arthralgia 5 5
Tissue Damage 5 5
Numbness 4 4
Bacterial Infection 4 4
Tissue Breakdown 4 4
Patient Problem/Medical Problem 4 4
Fibrosis 4 4
Fluid Discharge 4 4
Subluxation 4 4
Unspecified Musculoskeletal problem 3 3
Blister 3 3
Autoimmune Reaction 3 3
Hematoma 3 3
Sepsis 3 3
Urinary Tract Infection 3 3
Burning Sensation 3 3
Perforation 3 3
Rash 2 2
Renal Failure 2 2
Necrosis 2 2
Toxicity 2 2
Impaired Healing 2 2
Inadequate Pain Relief 2 2
High Blood Pressure/ Hypertension 2 2
Low Blood Pressure/ Hypotension 2 2
Edema 2 2
Muscle Weakness 2 2
Host-Tissue Reaction 2 2
Abrasion 2 2
Erosion 2 2
Rheumatoid Arthritis 2 2
Vascular Dissection 2 2
Lead(s), Burn(s) From 1 1
Unspecified Immune System Problem 1 1
Alteration In Body Temperature 1 1
Hormonal Imbalance 1 1
Breast Discomfort/Pain 1 1
Muscle/Tendon Damage 1 1
Aspiration/Inhalation 1 1
Autoimmune Disorder 1 1
Syncope 1 1
Abdominal Pain 1 1
Calcium Deposits/Calcification 1 1
Nausea 1 1
Irritation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Aesculap Implant Systems LLC II Sep-22-2021
2 Biomet U.K., Ltd. II Jun-29-2011
3 Biomet, Inc. II Jan-26-2023
4 Biomet, Inc. II Dec-17-2020
5 Biomet, Inc. II May-28-2020
6 Biomet, Inc. II Jun-15-2015
7 Biomet, Inc. II Jul-11-2013
8 DePuy Orthopaedics, Inc. II Mar-20-2018
9 Exactech, Inc. II Oct-04-2021
10 Materialise USA LLC II Jan-03-2014
11 MicroPort Orthopedics Inc. II Nov-22-2022
12 Stryker Howmedica Osteonics Corp. II Jan-12-2009
13 Zimmer Biomet, Inc. II Mar-27-2017
14 Zimmer Biomet, Inc. II Jan-06-2017
15 Zimmer, Inc. II Mar-20-2014
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