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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 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 1593
2026 215 215

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2258 2935
Fracture 420 472
Insufficient Information 404 408
Loosening of Implant Not Related to Bone-Ingrowth 239 887
Loss of Osseointegration 216 218
Device Dislodged or Dislocated 156 201
Detachment of Device or Device Component 146 149
Unstable 128 129
Naturally Worn 116 117
Device Appears to Trigger Rejection 114 114
Appropriate Term/Code Not Available 69 69
Patient-Device Incompatibility 67 67
Mechanical Problem 56 56
Osseointegration Problem 51 77
Migration 50 52
Degraded 49 49
Patient Device Interaction Problem 38 39
Break 37 37
Unintended Movement 37 38
Failure to Advance 27 27
Loose or Intermittent Connection 22 22
Separation Failure 21 21
Improper or Incorrect Procedure or Method 18 18
Material Erosion 18 618
Use of Device Problem 13 13
Loss of or Failure to Bond 12 12
No Apparent Adverse Event 12 12
Malposition of Device 11 547
Tear, Rip or Hole in Device Packaging 11 12
Inadequacy of Device Shape and/or Size 11 12
Shipping Damage or Problem 10 10
Corroded 9 9
Delivered as Unsterile Product 9 9
Noise, Audible 8 9
Activation Failure 8 8
Packaging Problem 8 8
Component Missing 8 8
Migration or Expulsion of Device 8 8
Off-Label Use 8 8
Nonstandard Device 7 7
Failure to Osseointegrate 7 7
Mechanical Jam 6 6
Expiration Date Error 6 6
Positioning Failure 6 6
Crack 6 6
Positioning Problem 5 5
Material Separation 5 5
Material Integrity Problem 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Material Fragmentation 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 1265 1934
Insufficient Information 896 1553
Failure of Implant 474 487
Pain 368 406
Joint Laxity 266 934
Inadequate Osseointegration 233 233
No Clinical Signs, Symptoms or Conditions 214 216
Joint Dislocation 169 706
Ambulation Difficulties 166 168
Fall 128 128
Bone Fracture(s) 107 748
Loss of Range of Motion 91 202
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 90 90
Implant Pain 60 62
Swelling/ Edema 56 58
Metal Related Pathology 50 51
Unequal Limb Length 48 49
Scar Tissue 46 48
Unspecified Tissue Injury 40 40
Adhesion(s) 33 33
Fluid Discharge 28 29
Inflammation 27 30
Hematoma 24 87
Hyperextension 23 23
Wound Dehiscence 22 23
Muscle/Tendon Damage 22 23
Osteolysis 21 152
Hypersensitivity/Allergic reaction 17 19
Muscular Rigidity 16 17
Foreign Body Reaction 16 16
Bacterial Infection 13 14
Synovitis 13 14
Cancer 12 12
Joint Contracture 12 12
Ulcer 10 10
Peripheral Nervous Injury 10 10
Post Traumatic Wound Infection 10 10
Osteopenia/ Osteoporosis 10 10
Discomfort 9 10
Arthralgia 9 114
Post Operative Wound Infection 8 8
Hemorrhage/Bleeding 8 9
Limb Fracture 8 8
Subluxation 7 7
Damage to Ligament(s) 6 6
Ossification 6 6
Foreign Body In Patient 5 5
Impaired Healing 5 69
Numbness 5 5
Necrosis 5 5

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 Mar-10-2026
8 Waldemar Link GmbH & Co. KG (Mfg Site) II Dec-09-2025
9 Waldemar Link GmbH & Co. KG (Mfg Site) II Jun-30-2023
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