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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
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 2
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 1
MICROPORT ORTHOPEDICS INC.
  SUBSTANTIALLY EQUIVALENT 2
ONKOS SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
STRYKER
  SUBSTANTIALLY EQUIVALENT 1
WALDEMAR LINK GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 2
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 749 749
2021 767 767
2022 893 893
2023 747 747
2024 858 858
2025 259 364

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1967 2072
Fracture 446 481
Insufficient Information 430 430
Loosening of Implant Not Related to Bone-Ingrowth 233 331
Loss of Osseointegration 216 216
Device Dislodged or Dislocated 169 204
Detachment of Device or Device Component 169 169
Unstable 149 149
Naturally Worn 122 122
Appropriate Term/Code Not Available 97 97
Device Appears to Trigger Rejection 91 91
Patient Device Interaction Problem 67 67
Migration 55 55
Break 54 54
Loose or Intermittent Connection 47 47
Patient-Device Incompatibility 45 45
Failure to Advance 43 43
Osseointegration Problem 40 40
Degraded 40 40
Unintended Movement 37 37
Mechanical Problem 34 34
Separation Failure 21 21
Inadequacy of Device Shape and/or Size 17 17
Use of Device Problem 17 17
Improper or Incorrect Procedure or Method 16 16
Malposition of Device 13 13
Material Erosion 13 55
Loss of or Failure to Bond 13 13
Compatibility Problem 12 12
Tear, Rip or Hole in Device Packaging 12 12
Packaging Problem 12 12
Noise, Audible 11 11
No Apparent Adverse Event 11 11
Shipping Damage or Problem 10 10
Material Fragmentation 10 10
Corroded 10 10
Connection Problem 9 9
Migration or Expulsion of Device 9 9
Activation Failure 9 9
Biocompatibility 8 8
Unsealed Device Packaging 8 8
Delivered as Unsterile Product 8 8
Failure to Osseointegrate 8 8
Mechanical Jam 8 8
Off-Label Use 7 7
Positioning Failure 7 7
Manufacturing, Packaging or Shipping Problem 7 7
Component Missing 7 7
Expiration Date Error 6 6
Material Separation 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 1195 1300
Insufficient Information 782 852
Failure of Implant 465 465
Pain 440 440
Joint Laxity 226 324
No Clinical Signs, Symptoms or Conditions 215 215
Inadequate Osseointegration 210 210
Ambulation Difficulties 172 172
Injury 152 152
Joint Dislocation 152 152
Fall 130 130
Bone Fracture(s) 125 230
No Code Available 96 96
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 88 88
Loss of Range of Motion 81 158
Cancer 61 61
No Information 59 59
Scar Tissue 56 56
Implant Pain 52 52
Unequal Limb Length 51 51
Swelling/ Edema 49 49
Metal Related Pathology 41 41
Inflammation 39 39
No Known Impact Or Consequence To Patient 36 36
Unspecified Tissue Injury 27 27
Adhesion(s) 23 23
Fluid Discharge 23 23
Hematoma 22 64
Hypersensitivity/Allergic reaction 21 21
Wound Dehiscence 21 21
Muscle/Tendon Damage 19 19
Hyperextension 17 17
Osteolysis 17 101
Foreign Body Reaction 15 15
Muscular Rigidity 14 14
Bacterial Infection 14 14
Osteopenia/ Osteoporosis 13 13
Joint Contracture 12 12
Synovitis 12 12
Joint Disorder 12 12
Necrosis 10 10
Post Traumatic Wound Infection 10 10
Post Operative Wound Infection 10 10
Swelling 10 10
Reaction 10 10
Patient Problem/Medical Problem 10 10
Ulcer 10 10
Damage to Ligament(s) 9 9
Ossification 9 9
Discomfort 9 9

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