Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device prosthesis, knee, femorotibial, constrained, cemented, metal/polymer
Regulation Description Knee joint femorotibial metal/polymer constrained cemented prosthesis.
Product CodeKRO
Regulation Number 888.3510
Device Class 2


Premarket Reviews
ManufacturerDecision
DEPUY IRELAND UC
  SUBSTANTIALLY EQUIVALENT 2
HOWMEDICA OSTEONICS CORP., DBA STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 4
MEDACTA INTERNATIONAL S.A.
  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

MDR Year MDR Reports MDR Events
2021 770 774
2022 892 910
2023 746 759
2024 855 859
2025 926 2708
2026 439 544

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2371 4268
Fracture 438 492
Insufficient Device Problem Information 413 417
Loosening of Implant Not Related to Bone-Ingrowth 245 2111
Loss of Osseointegration 224 226
Device Dislodged or Dislocated 153 251
Detachment of Device or Device Component 146 149
Unstable 131 132
Device Appears to Trigger Rejection 125 125
Naturally Worn 118 119
Patient-Device Incompatibility 66 66
Mechanical Problem 55 55
Degraded 52 52
Osseointegration Problem 51 79
Migration 50 52
Patient Device Interaction Problem 38 39
Unintended Movement 38 39
Break 37 37
Appropriate Device Problem Term/Code Not Available 32 32
Failure to Advance 27 27
Separation Failure 22 22
Material Erosion 19 1781
Improper or Incorrect Procedure or Method 15 15
Loose or Intermittent Connection 15 15
Use of Device Problem 13 13
Malposition of Device 12 1659
No Apparent Adverse Event 12 12
Inadequacy of Device Shape and/or Size 11 12
Tear, Rip or Hole in Device Packaging 11 12
Loss of or Failure to Bond 11 11
Corroded 10 10
Delivered as Unsterile Product 10 10
Device Damaged Prior to Receipt by User 10 10
Noise, Audible 9 10
Migration or Expulsion of Device 8 8
Off-Label Use 8 8
Activation Failure 8 8
Packaging Problem 8 8
Component Missing 8 8
Mechanical Jam 7 7
Failure to Osseointegrate 7 7
Nonstandard Device 6 6
Deformation Due to Compressive Stress 6 6
Positioning Failure 6 6
Expiration Date Error 6 6
Crack 5 5
Device-Device Incompatibility 5 5
Device Difficult to Maintain 4 4
Positioning Problem 4 4
Material Integrity Problem 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 1308 3197
Insufficient Information 929 2804
Medical device site infection 580 580
Failure of Implant 477 490
Pain 387 478
Joint Laxity 287 2070
Inadequate Osseointegration 238 238
No Clinical Signs, Symptoms or Conditions 224 226
Joint Dislocation 185 1938
Ambulation or Postural Difficulties 170 172
Fall 131 131
Bone Fracture(s) 110 1864
Loss of Range of Motion 100 264
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 91 91
Swelling/ Edema 65 67
Implant Pain 62 64
Aseptic loosening 61 1948
Metal Related Pathology 51 52
Unequal Limb Length 49 50
Scar Tissue 46 48
Periprosthetic fracture 45 223
Unspecified Tissue Injury 41 41
Adhesion(s) 33 33
Hyperextension 30 30
Fluid Discharge 28 29
Inflammation 27 30
Hematoma 25 88
Wound Dehiscence 24 25
Muscle/Tendon Damage 22 23
Osteolysis 22 208
Hypersensitivity/Allergic reaction 17 19
Foreign Body Reaction 16 16
Septic loosening 16 16
Muscular Rigidity 16 17
Bacterial Infection 14 15
Limb Pain 14 14
Synovitis 13 14
Joint Contracture 12 12
Cancer 12 12
Wound Infection 11 11
Fever 11 11
Peripheral Nervous Injury 10 10
Osteopenia/ Osteoporosis 10 10
Ulcer 10 10
Hemorrhage/Blood Loss/Bleeding 9 10
Arthralgia 9 116
Discomfort 9 10
Limb Fracture 8 8
Subluxation 8 8
Post Operative Wound Infection 8 8

Recalls
Manufacturer Recall Class Date Posted
1 DEPUY (IRELAND) II Jun-29-2026
2 DEPUY (IRELAND) II Apr-29-2026
3 DePuy Orthopaedics, Inc. II Mar-17-2023
4 Linkbio Corp. II May-04-2023
5 Onkos Surgical, Inc. II May-29-2025
6 Onkos Surgical, Inc. II May-28-2025
7 United Orthopedic Corporation II Feb-29-2024
8 Uoc Usa Inc II Oct-14-2021
9 Waldemar Link GmbH & Co. KG (Mfg Site) II Mar-10-2026
10 Waldemar Link GmbH & Co. KG (Mfg Site) II Dec-09-2025
11 Waldemar Link GmbH & Co. KG (Mfg Site) II Jun-30-2023
-
-