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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, constrained, cemented, metal/polymer
Product CodeKRO
Regulation Number 888.3510
Device Class 2


Premarket Reviews
ManufacturerDecision
DEPUY (IRELAND)
  SUBSTANTIALLY EQUIVALENT 1
HOWMEDICA OSTEONICS CORP. DBA STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 2
LINK BIO CORP.
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 1
ONKOS SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
STRYKER
  SUBSTANTIALLY EQUIVALENT 1
UNITED ORTHOPEDIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
WALDEMAR LINK GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 2
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 614 614
2019 759 759
2020 749 749
2021 767 767
2022 893 893
2023 495 495

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1590 1590
Insufficient Information 635 635
Fracture 430 430
Loss of Osseointegration 257 257
Device Dislodged or Dislocated 193 193
Unstable 185 185
Detachment of Device or Device Component 168 168
Loosening of Implant Not Related to Bone-Ingrowth 164 164
Appropriate Term/Code Not Available 142 142
Naturally Worn 141 141
Break 127 127
Loose or Intermittent Connection 61 61
Mechanical Problem 54 54
Patient Device Interaction Problem 54 54
Migration 49 49
Failure to Advance 49 49
Degraded 47 47
Migration or Expulsion of Device 37 37
Unintended Movement 37 37
Osseointegration Problem 30 30
Device Appears to Trigger Rejection 27 27
Compatibility Problem 26 26
Patient-Device Incompatibility 20 20
Noise, Audible 19 19
Packaging Problem 18 18
Malposition of Device 18 18
Inadequacy of Device Shape and/or Size 18 18
Separation Failure 16 16
Material Deformation 16 16
Use of Device Problem 15 15
Mechanical Jam 14 14
Improper or Incorrect Procedure or Method 13 13
Component Missing 13 13
Material Erosion 13 13
Loss of or Failure to Bond 12 12
Material Fragmentation 12 12
Delivered as Unsterile Product 12 12
Crack 11 11
Tear, Rip or Hole in Device Packaging 10 10
Shipping Damage or Problem 10 10
Detachment Of Device Component 9 9
Unsealed Device Packaging 9 9
Manufacturing, Packaging or Shipping Problem 9 9
No Apparent Adverse Event 9 9
Material Integrity Problem 9 9
Connection Problem 9 9
Activation Failure 8 8
Positioning Failure 8 8
Disassembly 8 8
Off-Label Use 7 7
Contamination /Decontamination Problem 7 7
Device Slipped 6 6
Corroded 6 6
Difficult to Insert 6 6
Component Incompatible 5 5
Device Contaminated During Manufacture or Shipping 5 5
Device Damaged by Another Device 5 5
Device-Device Incompatibility 5 5
Positioning Problem 4 4
Unclear Information 4 4
Material Disintegration 4 4
Material Separation 4 4
Failure to Osseointegrate 4 4
Expiration Date Error 4 4
Fitting Problem 3 3
Defective Component 3 3
Microbial Contamination of Device 3 3
Material Rupture 3 3
No Device Output 3 3
Separation Problem 3 3
Difficult or Delayed Separation 3 3
Sharp Edges 3 3
Scratched Material 3 3
Material Twisted/Bent 3 3
Device Contamination with Chemical or Other Material 2 2
Operating System Becomes Nonfunctional 2 2
Device Handling Problem 2 2
Misassembly by Users 2 2
Physical Resistance/Sticking 2 2
Activation Problem 2 2
Nonstandard Device 2 2
Device Difficult to Setup or Prepare 2 2
Disconnection 2 2
Difficult or Delayed Positioning 2 2
Product Quality Problem 2 2
Device Damaged Prior to Use 2 2
Defective Device 2 2
Biocompatibility 2 2
Failure to Align 2 2
Difficult or Delayed Activation 1 1
Dent in Material 1 1
Component or Accessory Incompatibility 1 1
Ambient Noise Problem 1 1
Metal Shedding Debris 1 1
Difficult to Remove 1 1
Unexpected Therapeutic Results 1 1
Material Discolored 1 1
Electrical /Electronic Property Problem 1 1
Contamination 1 1
Failure To Adhere Or Bond 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 1299 1299
Insufficient Information 542 542
Injury 538 538
Pain 521 521
Failure of Implant 416 416
Inadequate Osseointegration 247 247
No Information 241 241
No Code Available 220 220
No Clinical Signs, Symptoms or Conditions 164 164
Cancer 150 150
Ambulation Difficulties 140 140
Bone Fracture(s) 138 138
Fall 134 134
Joint Laxity 108 108
Joint Dislocation 106 106
No Known Impact Or Consequence To Patient 92 93
Loss of Range of Motion 83 83
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 62 62
Patient Problem/Medical Problem 59 59
Swelling 56 56
Unequal Limb Length 50 50
Scar Tissue 49 49
Limited Mobility Of The Implanted Joint 42 42
Joint Disorder 40 40
Inflammation 39 39
Swelling/ Edema 34 34
No Consequences Or Impact To Patient 27 27
Reaction 25 25
Death 24 24
Hematoma 22 22
Metal Related Pathology 22 22
Not Applicable 22 22
Osteolysis 19 19
Post Operative Wound Infection 19 19
Wound Dehiscence 18 18
Bacterial Infection 17 17
Fluid Discharge 17 17
Unspecified Tissue Injury 16 16
Foreign Body Reaction 15 15
Synovitis 13 13
Muscular Rigidity 13 13
Muscle/Tendon Damage 13 13
Tissue Damage 11 11
Ulcer 10 10
Discomfort 10 10
Thrombosis 10 10
Adhesion(s) 10 10
Hyperextension 10 10
Implant Pain 9 9
Necrosis 9 9
Ossification 8 8
Edema 8 8
Damage to Ligament(s) 8 8
No Patient Involvement 8 8
Post Traumatic Wound Infection 8 8
Sudden Cardiac Death 8 8
Joint Contracture 7 7
Staphylococcus Aureus 7 7
Skin Discoloration 7 7
Hemorrhage/Bleeding 7 7
Hypersensitivity/Allergic reaction 6 6
Blood Loss 6 6
Osteopenia/ Osteoporosis 5 5
Foreign Body In Patient 5 5
Impaired Healing 4 4
Fever 4 4
Host-Tissue Reaction 4 4
Rash 4 4
Hip Fracture 4 4
Sepsis 4 4
Discharge 4 4
Hypovolemia 4 4
Rupture 3 3
Joint Swelling 3 3
Ischemia 3 3
Limb Fracture 3 3
Device Embedded In Tissue or Plaque 2 2
Fibrosis 2 2
Subluxation 2 2
Unspecified Musculoskeletal problem 2 2
Fungal Infection 2 2
Weight Changes 2 2
Anemia 2 2
Erythema 2 2
Stroke/CVA 2 2
Abdominal Pain 2 2
Abscess 2 2
Toxicity 2 2
Scarring 2 2
Skin Erosion 1 1
Local Reaction 1 1
Renal Failure 1 1
Myocardial Infarction 1 1
Perforation 1 1
Arthralgia 1 1
Non-union Bone Fracture 1 1
Weakness 1 1
Distress 1 1
Calcium Deposits/Calcification 1 1
Cellulitis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 DePuy Orthopaedics, Inc. II Mar-17-2023
2 Linkbio Corp. II May-04-2023
3 Smith & Nephew, Inc. II Mar-19-2018
4 Uoc Usa Inc II Oct-14-2021
5 Waldemar Link GmbH & Co. KG (Mfg Site) II Jun-30-2023
6 Zimmer Biomet, Inc. II Dec-07-2018
7 Zimmer Biomet, Inc. II Feb-26-2018
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