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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
DEPUY IRELAND UC
  SUBSTANTIALLY EQUIVALENT 1
HOWMEDICA OSTEONICS CORP. DBA STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 2
LINK BIO CORP.
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 1
MICROPORT ORTHOPEDICS INC.
  SUBSTANTIALLY EQUIVALENT 2
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
2019 759 759
2020 749 749
2021 767 767
2022 893 893
2023 746 746
2024 187 187

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1601 1601
Insufficient Information 530 530
Fracture 422 422
Loss of Osseointegration 246 246
Loosening of Implant Not Related to Bone-Ingrowth 202 202
Device Dislodged or Dislocated 180 180
Unstable 168 168
Detachment of Device or Device Component 157 157
Naturally Worn 141 141
Appropriate Term/Code Not Available 132 132
Break 87 87
Patient Device Interaction Problem 78 78
Device Appears to Trigger Rejection 67 67
Loose or Intermittent Connection 57 57
Degraded 53 53
Failure to Advance 49 49
Mechanical Problem 46 46
Patient-Device Incompatibility 40 40
Migration 39 39
Osseointegration Problem 38 38
Unintended Movement 36 36
Compatibility Problem 26 26
Separation Failure 18 18
Malposition of Device 18 18
Use of Device Problem 17 17
Inadequacy of Device Shape and/or Size 16 16
Packaging Problem 16 16
Mechanical Jam 15 15
Noise, Audible 14 14
Material Erosion 14 14
Delivered as Unsterile Product 14 14
Material Fragmentation 12 12
Component Missing 12 12
No Apparent Adverse Event 12 12
Tear, Rip or Hole in Device Packaging 11 11
Improper or Incorrect Procedure or Method 11 11
Shipping Damage or Problem 11 11
Loss of or Failure to Bond 11 11
Migration or Expulsion of Device 11 11
Crack 10 10
Material Deformation 10 10
Material Integrity Problem 9 9
Connection Problem 9 9
Manufacturing, Packaging or Shipping Problem 9 9
Activation Failure 9 9
Corroded 8 8
Unsealed Device Packaging 8 8
Off-Label Use 7 7
Positioning Failure 7 7
Failure to Osseointegrate 6 6
Contamination /Decontamination Problem 5 5
Device Damaged by Another Device 5 5
Device-Device Incompatibility 5 5
Device Contaminated During Manufacture or Shipping 5 5
Human-Device Interface Problem 4 4
Positioning Problem 4 4
Device Difficult to Maintain 4 4
Expiration Date Error 4 4
Collapse 4 4
Component Incompatible 4 4
Material Disintegration 3 3
Difficult to Insert 3 3
No Device Output 3 3
Biocompatibility 3 3
Material Rupture 3 3
Material Separation 3 3
Fitting Problem 3 3
Sharp Edges 3 3
Material Twisted/Bent 3 3
Difficult or Delayed Separation 3 3
Physical Resistance/Sticking 2 2
Separation Problem 2 2
Unclear Information 2 2
Operating System Becomes Nonfunctional 2 2
Device Damaged Prior to Use 2 2
Defective Component 2 2
Microbial Contamination of Device 2 2
Failure to Align 2 2
Device Difficult to Setup or Prepare 2 2
Device Slipped 2 2
Defective Device 2 2
Product Quality Problem 2 2
Misassembled 2 2
Nonstandard Device 2 2
Difficult or Delayed Positioning 2 2
Contamination 1 1
Labelling, Instructions for Use or Training Problem 1 1
Material Frayed 1 1
Material Discolored 1 1
Incorrect Measurement 1 1
Misconnection 1 1
Difficult to Remove 1 1
Peeled/Delaminated 1 1
Failure to Power Up 1 1
Ambient Noise Problem 1 1
Difficult or Delayed Activation 1 1
Dent in Material 1 1
Component or Accessory Incompatibility 1 1
Difficult to Open or Remove Packaging Material 1 1
Device Misassembled During Manufacturing /Shipping 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 1204 1204
Insufficient Information 649 649
Pain 477 477
Failure of Implant 433 433
Injury 360 360
Inadequate Osseointegration 218 218
No Clinical Signs, Symptoms or Conditions 186 186
No Code Available 174 174
Joint Laxity 159 159
No Information 151 151
Ambulation Difficulties 147 147
Bone Fracture(s) 131 131
Fall 131 131
Cancer 118 118
Joint Dislocation 113 113
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 76 76
Loss of Range of Motion 75 75
No Known Impact Or Consequence To Patient 66 67
Scar Tissue 57 57
Unequal Limb Length 51 51
Patient Problem/Medical Problem 48 48
Swelling 42 42
Inflammation 39 39
Swelling/ Edema 38 38
Metal Related Pathology 37 37
Joint Disorder 30 30
Implant Pain 28 28
Limited Mobility Of The Implanted Joint 26 26
Death 23 23
Adhesion(s) 21 21
Hematoma 21 21
Unspecified Tissue Injury 20 20
Post Operative Wound Infection 19 19
Reaction 18 18
Bacterial Infection 18 18
Wound Dehiscence 17 17
Fluid Discharge 17 17
Foreign Body Reaction 16 16
Muscular Rigidity 14 14
No Consequences Or Impact To Patient 14 14
Synovitis 13 13
Hypersensitivity/Allergic reaction 13 13
Muscle/Tendon Damage 13 13
Hyperextension 12 12
Necrosis 10 10
Post Traumatic Wound Infection 10 10
Ulcer 10 10
Discomfort 9 9
Osteolysis 9 9
Tissue Damage 9 9
Damage to Ligament(s) 9 9
Ossification 8 8
Edema 8 8
Osteopenia/ Osteoporosis 8 8
No Patient Involvement 8 8
Not Applicable 7 7
Joint Contracture 7 7
Hemorrhage/Bleeding 7 7
Skin Discoloration 7 7
Blood Loss 5 5
Foreign Body In Patient 4 4
Thrombosis 4 4
Staphylococcus Aureus 4 4
Sepsis 4 4
Impaired Healing 4 4
Hypovolemia 4 4
Hip Fracture 4 4
Arthralgia 4 4
Joint Swelling 3 3
Numbness 3 3
Rupture 3 3
Ischemia 3 3
Anemia 3 3
Fibrosis 3 3
Subluxation 3 3
Limb Fracture 3 3
Unspecified Musculoskeletal problem 3 3
Bone Shedding Debris 2 2
Device Embedded In Tissue or Plaque 2 2
Weight Changes 2 2
Stroke/CVA 2 2
Erythema 2 2
Fever 2 2
Abdominal Pain 2 2
Abscess 2 2
Discharge 2 2
Scarring 2 2
Rash 2 2
Fungal Infection 2 2
Toxicity 2 2
Distress 1 1
Non-union Bone Fracture 1 1
Local Reaction 1 1
Renal Failure 1 1
Weakness 1 1
Skin Erosion 1 1
Host-Tissue Reaction 1 1
Erosion 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 United Orthopedic Corporation II Feb-29-2024
4 Uoc Usa Inc II Oct-14-2021
5 Waldemar Link GmbH & Co. KG (Mfg Site) II Jun-30-2023
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