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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
AESCULAP IMPLANT SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
BIOMET MANUFACTURING CORP.
  SUBSTANTIALLY EQUIVALENT 2
BIOMET MANUFACTURING LLC
  SUBSTANTIALLY EQUIVALENT 1
BIOMET ORTHOPEDICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
DEPUY (IRELAND)
  SUBSTANTIALLY EQUIVALENT 1
DEPUY IRELAND UC
  SUBSTANTIALLY EQUIVALENT 1
DEPUY ORTHOPAEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
HOWMEDICA OSTEONICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
HOWMEDICA OSTEONICS CORP. DBA STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 2
LINK BIO CORP.
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 3
MICROPORT ORTHOPEDICS INC.
  SUBSTANTIALLY EQUIVALENT 2
ONKOS SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
ONKOS SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW
  SUBSTANTIALLY EQUIVALENT 1
STANMORE IMPLANTS WORLDWIDE LTD
  SUBSTANTIALLY EQUIVALENT 2
STANMORE IMPLANTS WORLDWIDE LTD.
  SUBSTANTIALLY EQUIVALENT 3
STANMORE WORLDWIDE IMPLANTS LTD.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER
  SUBSTANTIALLY EQUIVALENT 1
UNITED ORTHOPEDIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
WALDEMAR LINK GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 5
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2014 406 406
2015 333 333
2016 369 369
2017 542 542
2018 614 614
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 2051 2051
Insufficient Information 1157 1157
Fracture 618 618
Device Dislodged or Dislocated 303 303
Loss of Osseointegration 294 294
Break 261 261
Unstable 252 252
Detachment of Device or Device Component 206 206
Loosening of Implant Not Related to Bone-Ingrowth 206 206
Naturally Worn 197 197
Appropriate Term/Code Not Available 192 192
Loose or Intermittent Connection 117 117
Migration or Expulsion of Device 108 108
Mechanical Problem 81 81
Patient Device Interaction Problem 79 79
Device Appears to Trigger Rejection 67 67
Degraded 58 58
Disassembly 58 58
Unintended Movement 54 54
Migration 53 53
Patient-Device Incompatibility 51 51
Failure to Advance 51 51
Packaging Problem 50 50
Osseointegration Problem 40 40
Device Operates Differently Than Expected 36 36
Noise, Audible 36 36
Inadequacy of Device Shape and/or Size 31 31
Tear, Rip or Hole in Device Packaging 29 29
Compatibility Problem 29 29
Material Integrity Problem 29 29
Device Slipped 28 28
Malposition of Device 27 27
Component Missing 27 27
Fitting Problem 25 25
Loss of or Failure to Bond 25 25
Failure To Adhere Or Bond 24 24
Use of Device Problem 24 24
Detachment Of Device Component 23 23
Mechanical Jam 23 23
Material Erosion 22 22
Delivered as Unsterile Product 22 22
Manufacturing, Packaging or Shipping Problem 21 21
Device Packaging Compromised 20 20
Improper or Incorrect Procedure or Method 20 20
Separation Failure 19 19
Material Deformation 18 18
Crack 18 18
Unsealed Device Packaging 16 16
Shipping Damage or Problem 14 14
Device Damaged Prior to Use 14 14
Incorrect Device Or Component Shipped 14 14
Device Contamination with Chemical or Other Material 14 14
No Apparent Adverse Event 13 13
Connection Problem 12 12
Metal Shedding Debris 12 12
Material Fragmentation 12 12
Positioning Failure 12 12
Difficult to Insert 12 12
Activation Failure 11 11
Off-Label Use 10 10
Device Contaminated During Manufacture or Shipping 10 10
Device-Device Incompatibility 10 10
Material Separation 9 9
Corroded 9 9
Device Markings/Labelling Problem 8 8
Contamination /Decontamination Problem 8 8
Device Issue 8 8
Out-Of-Box Failure 7 7
Device Damaged by Another Device 7 7
Positioning Problem 7 7
Defective Component 7 7
Failure to Osseointegrate 6 6
Scratched Material 6 6
Failure to Align 6 6
Component or Accessory Incompatibility 6 6
Product Quality Problem 5 5
No Device Output 5 5
Source, incorrect 5 5
Component Incompatible 5 5
Contamination 5 5
Collapse 5 5
Labelling, Instructions for Use or Training Problem 5 5
Material Disintegration 4 4
Difficult to Remove 4 4
Contamination of Device Ingredient or Reagent 4 4
Expiration Date Error 4 4
Device Difficult to Maintain 4 4
Human-Device Interface Problem 4 4
Unclear Information 4 4
Sharp Edges 3 3
Activation Problem 3 3
Separation Problem 3 3
Difficult or Delayed Separation 3 3
Material Twisted/Bent 3 3
Incomplete or Missing Packaging 3 3
Biocompatibility 3 3
Material Rupture 3 3
Microbial Contamination of Device 3 3
Disconnection 3 3
Nonstandard Device 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 1623 1623
Pain 769 769
Insufficient Information 657 657
Injury 630 630
Failure of Implant 552 552
No Information 550 550
No Code Available 418 418
Cancer 402 402
No Known Impact Or Consequence To Patient 302 303
Inadequate Osseointegration 271 271
Bone Fracture(s) 204 204
No Clinical Signs, Symptoms or Conditions 186 186
Fall 170 170
Joint Laxity 162 162
Ambulation Difficulties 162 162
Joint Dislocation 158 158
Limited Mobility Of The Implanted Joint 121 121
Loss of Range of Motion 104 104
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 77 77
Swelling 71 71
No Consequences Or Impact To Patient 65 65
Patient Problem/Medical Problem 62 62
Scar Tissue 58 58
Unequal Limb Length 51 51
Reaction 51 51
Joint Disorder 46 46
Inflammation 42 42
Swelling/ Edema 38 38
Metal Related Pathology 37 37
Osteolysis 31 31
Discomfort 29 29
Hematoma 29 29
Implant Pain 28 28
Death 26 26
Wound Dehiscence 26 26
Post Operative Wound Infection 25 25
Bacterial Infection 24 24
Foreign Body Reaction 22 22
Not Applicable 22 22
Adhesion(s) 21 21
Necrosis 21 21
Synovitis 20 20
Unspecified Tissue Injury 20 20
Fluid Discharge 17 17
No Patient Involvement 17 17
Tissue Damage 17 17
Hypersensitivity/Allergic reaction 16 16
Fibrosis 16 16
Thrombosis 14 14
Muscular Rigidity 14 14
Muscle/Tendon Damage 13 13
Hyperextension 12 12
Toxicity 12 12
Post Traumatic Wound Infection 11 11
Ulcer 10 10
Damage to Ligament(s) 10 10
Ossification 10 10
Skin Discoloration 9 9
Arthralgia 9 9
Osteopenia/ Osteoporosis 9 9
Device Embedded In Tissue or Plaque 9 9
Sudden Cardiac Death 8 8
Cellulitis 8 8
Edema 8 8
Hemorrhage/Bleeding 7 7
Host-Tissue Reaction 7 7
Staphylococcus Aureus 7 7
Joint Contracture 7 7
Blood Loss 6 6
Fungal Infection 6 6
Foreign Body In Patient 6 6
Rupture 6 6
Discharge 6 6
Sepsis 5 5
Peroneal Nerve Palsy 5 5
Impaired Healing 5 5
Joint Swelling 4 4
Hip Fracture 4 4
Test Result 4 4
Hypovolemia 4 4
Viral Infection 4 4
Muscle Weakness 4 4
Rash 4 4
Fever 4 4
Erythema 3 3
Anemia 3 3
Arthritis 3 3
Seroma 3 3
Ischemia 3 3
Subluxation 3 3
Limb Fracture 3 3
Unspecified Musculoskeletal problem 3 3
Complaint, Ill-Defined 3 3
Numbness 3 3
Weight Changes 2 2
Non-union Bone Fracture 2 2
Bone Shedding Debris 2 2
Lymphoma 2 2
Scarring 2 2
Perforation 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Apr-19-2012
2 Biomet, Inc. II Jan-11-2012
3 Biomet, Inc. II Jun-29-2009
4 DePuy Orthopaedics, Inc. II Mar-17-2023
5 DePuy Orthopaedics, Inc. II Mar-13-2014
6 Linkbio Corp. II May-04-2023
7 Medacta Usa II Nov-14-2015
8 Medacta Usa Inc II Jun-12-2017
9 Onkos Surgical, Inc. II Jun-29-2017
10 Smith & Nephew, Inc. II Mar-19-2018
11 Smith & Nephew, Inc. II Jun-29-2016
12 Stanmore Implants Worldwide Ltd. II Sep-05-2017
13 Stanmore Implants Worldwide Ltd. II Dec-19-2016
14 Stanmore Implants Worldwide Ltd. II Aug-17-2016
15 Stryker Howmedica Osteonics Corp. II Sep-29-2010
16 Stryker Howmedica Osteonics Corp. II Apr-17-2009
17 United Orthopedic Corporation II Feb-29-2024
18 Uoc Usa Inc II Oct-14-2021
19 Waldemar Link GmbH & Co. KG (Mfg Site) II Jun-30-2023
20 Zimmer Biomet, Inc. II Dec-07-2018
21 Zimmer Biomet, Inc. II Feb-26-2018
22 Zimmer Biomet, Inc. II Dec-29-2017
23 Zimmer Biomet, Inc. II Nov-08-2017
24 Zimmer Biomet, Inc. II Mar-20-2017
25 Zimmer Biomet, Inc. II Jan-28-2017
26 Zimmer Inc. II Mar-09-2009
27 Zimmer, Inc. II Mar-20-2014
28 Zimmer, Inc. II Jan-17-2014
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