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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 537 537

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2246 2246
Insufficient Information 1215 1215
Fracture 658 658
Device Dislodged or Dislocated 313 313
Loss of Osseointegration 295 295
Break 262 262
Unstable 256 256
Loosening of Implant Not Related to Bone-Ingrowth 228 228
Detachment of Device or Device Component 225 225
Naturally Worn 198 198
Appropriate Term/Code Not Available 193 193
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 74 74
Degraded 59 59
Disassembly 58 58
Migration 56 56
Unintended Movement 55 55
Patient-Device Incompatibility 52 52
Failure to Advance 51 51
Packaging Problem 50 50
Osseointegration Problem 40 40
Noise, Audible 36 36
Device Operates Differently Than Expected 36 36
Inadequacy of Device Shape and/or Size 32 32
Tear, Rip or Hole in Device Packaging 31 31
Compatibility Problem 29 29
Malposition of Device 29 29
Material Integrity Problem 29 29
Device Slipped 28 28
Component Missing 27 27
Fitting Problem 25 25
Loss of or Failure to Bond 25 25
Improper or Incorrect Procedure or Method 24 24
Use of Device Problem 24 24
Failure To Adhere Or Bond 24 24
Material Erosion 24 24
Detachment Of Device Component 23 23
Mechanical Jam 23 23
Delivered as Unsterile Product 22 22
Manufacturing, Packaging or Shipping Problem 21 21
Separation Failure 20 20
Device Packaging Compromised 20 20
Material Deformation 19 19
Crack 18 18
Unsealed Device Packaging 16 16
Device Contamination with Chemical or Other Material 14 14
Device Damaged Prior to Use 14 14

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 1677 1677
Pain 800 800
Insufficient Information 720 720
Injury 630 630
Failure of Implant 596 596
No Information 550 550
No Code Available 418 418
Cancer 402 402
No Known Impact Or Consequence To Patient 302 303
Inadequate Osseointegration 275 275
Bone Fracture(s) 212 212
No Clinical Signs, Symptoms or Conditions 199 199
Joint Laxity 187 187
Joint Dislocation 182 182
Fall 174 174
Ambulation Difficulties 173 173
Limited Mobility Of The Implanted Joint 121 121
Loss of Range of Motion 111 111
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 80 80
Swelling 71 71
No Consequences Or Impact To Patient 65 65
Patient Problem/Medical Problem 62 62
Scar Tissue 59 59
Unequal Limb Length 54 54
Reaction 51 51
Joint Disorder 46 46
Inflammation 45 45
Metal Related Pathology 39 39
Swelling/ Edema 39 39
Osteolysis 34 34
Implant Pain 34 34
Hematoma 30 30
Discomfort 29 29
Wound Dehiscence 28 28
Death 26 26
Post Operative Wound Infection 25 25
Bacterial Infection 25 25
Unspecified Tissue Injury 24 24
Not Applicable 22 22
Adhesion(s) 22 22
Foreign Body Reaction 22 22
Necrosis 21 21
Synovitis 21 21
Fluid Discharge 19 19
Hypersensitivity/Allergic reaction 19 19
No Patient Involvement 17 17
Tissue Damage 17 17
Fibrosis 16 16
Muscle/Tendon Damage 14 14
Thrombosis 14 14

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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