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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
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
MICROPORT ORTHOPEDICS INC.
  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
2019 759 759
2020 749 749
2021 767 767
2022 893 893
2023 744 744
2024 55 55

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1525 1525
Insufficient Information 516 516
Fracture 406 406
Loss of Osseointegration 245 245
Loosening of Implant Not Related to Bone-Ingrowth 192 192
Device Dislodged or Dislocated 178 178
Unstable 167 167
Detachment of Device or Device Component 152 152
Naturally Worn 141 141
Appropriate Term/Code Not Available 132 132
Break 87 87
Patient Device Interaction Problem 74 74
Device Appears to Trigger Rejection 57 57
Loose or Intermittent Connection 54 54
Degraded 53 53
Failure to Advance 49 49
Mechanical Problem 46 46
Patient-Device Incompatibility 39 39
Osseointegration Problem 36 36
Unintended Movement 35 35
Migration 35 35
Compatibility Problem 26 26
Malposition of Device 17 17
Use of Device Problem 17 17
Separation Failure 16 16
Inadequacy of Device Shape and/or Size 15 15
Packaging Problem 15 15
Mechanical Jam 14 14
Noise, Audible 13 13
Material Erosion 13 13
Delivered as Unsterile Product 13 13
Material Fragmentation 12 12
Component Missing 12 12
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
Tear, Rip or Hole in Device Packaging 10 10
Material Deformation 10 10
Material Integrity Problem 9 9
Manufacturing, Packaging or Shipping Problem 9 9
No Apparent Adverse Event 9 9
Activation Failure 8 8
Connection Problem 8 8
Corroded 8 8
Unsealed Device Packaging 8 8
Off-Label Use 7 7
Positioning Failure 7 7
Failure to Osseointegrate 5 5
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
Material Rupture 3 3
Material Separation 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 Difficult to Setup or Prepare 2 2
Device Slipped 2 2
Failure to Align 2 2
Defective Component 2 2
Microbial Contamination of Device 2 2
Defective Device 2 2
Biocompatibility 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
Component or Accessory Incompatibility 1 1
Difficult to Open or Remove Packaging Material 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Ambient Noise Problem 1 1
Difficult or Delayed Activation 1 1
Dent in Material 1 1
Device Damaged Prior to Use 1 1
Unexpected Therapeutic Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 1199 1199
Insufficient Information 621 621
Pain 455 455
Failure of Implant 425 425
Injury 360 360
Inadequate Osseointegration 216 216
No Clinical Signs, Symptoms or Conditions 177 177
No Code Available 174 174
No Information 151 151
Ambulation Difficulties 143 143
Joint Laxity 132 132
Fall 131 131
Bone Fracture(s) 128 128
Cancer 118 118
Joint Dislocation 106 106
Loss of Range of Motion 74 74
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 73 73
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
Joint Disorder 30 30
Metal Related Pathology 27 27
Limited Mobility Of The Implanted Joint 26 26
Death 23 23
Hematoma 21 21
Unspecified Tissue Injury 20 20
Post Operative Wound Infection 19 19
Reaction 18 18
Adhesion(s) 18 18
Implant Pain 18 18
Fluid Discharge 17 17
Bacterial Infection 17 17
Wound Dehiscence 16 16
Foreign Body Reaction 16 16
Muscular Rigidity 14 14
No Consequences Or Impact To Patient 14 14
Muscle/Tendon Damage 13 13
Synovitis 13 13
Hyperextension 12 12
Necrosis 10 10
Ulcer 10 10
Tissue Damage 9 9
Damage to Ligament(s) 9 9
Osteolysis 9 9
Discomfort 9 9
Post Traumatic Wound Infection 8 8
Hypersensitivity/Allergic reaction 8 8
Edema 8 8
No Patient Involvement 8 8
Ossification 8 8
Skin Discoloration 7 7
Not Applicable 7 7
Hemorrhage/Bleeding 7 7
Joint Contracture 7 7
Blood Loss 5 5
Osteopenia/ Osteoporosis 5 5
Staphylococcus Aureus 4 4
Hypovolemia 4 4
Foreign Body In Patient 4 4
Arthralgia 4 4
Thrombosis 4 4
Sepsis 4 4
Hip Fracture 4 4
Impaired Healing 4 4
Fibrosis 3 3
Unspecified Musculoskeletal problem 3 3
Limb Fracture 3 3
Ischemia 3 3
Anemia 3 3
Joint Swelling 3 3
Rupture 3 3
Erythema 2 2
Abscess 2 2
Fungal Infection 2 2
Rash 2 2
Toxicity 2 2
Fever 2 2
Scarring 2 2
Device Embedded In Tissue or Plaque 2 2
Weight Changes 2 2
Bone Shedding Debris 2 2
Discharge 2 2
Abdominal Pain 2 2
Stroke/CVA 2 2
Subluxation 2 2
Cellulitis 1 1
Malunion of Bone 1 1
Embolism/Embolus 1 1
Osteomyelitis 1 1
Cyst(s) 1 1
Infiltration into Tissue 1 1
Tissue Breakdown 1 1
Weakness 1 1
Local Reaction 1 1
Non-union Bone Fracture 1 1
Skin Erosion 1 1

Recalls
Manufacturer Recall Class Date Posted
1 DePuy Orthopaedics, Inc. II Mar-17-2023
2 Linkbio Corp. II May-04-2023
3 Uoc Usa Inc II Oct-14-2021
4 Waldemar Link GmbH & Co. KG (Mfg Site) II Jun-30-2023
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