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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
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 749 749
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 2572 4469
Fracture 522 576
Insufficient Device Problem Information 493 497
Loss of Osseointegration 294 296
Loosening of Implant Not Related to Bone-Ingrowth 269 2135
Device Dislodged or Dislocated 192 290
Detachment of Device or Device Component 175 178
Unstable 165 166
Naturally Worn 136 137
Device Appears to Trigger Rejection 126 126
Patient Device Interaction Problem 72 73
Patient-Device Incompatibility 67 67
Mechanical Problem 57 57
Migration 57 59
Degraded 56 56
Osseointegration Problem 55 83
Break 50 50
Failure to Advance 44 44
Unintended Movement 43 44
Loose or Intermittent Connection 36 36
Appropriate Device Problem Term/Code Not Available 34 34
Separation Failure 23 23
Material Erosion 20 1782
Inadequacy of Device Shape and/or Size 18 19
Use of Device Problem 17 17
Malposition of Device 16 1663
Improper or Incorrect Procedure or Method 15 15
Loss of or Failure to Bond 14 14
Compatibility Problem 13 13
No Apparent Adverse Event 13 13
Noise, Audible 12 13
Tear, Rip or Hole in Device Packaging 12 13
Packaging Problem 12 12
Corroded 11 11
Delivered as Unsterile Product 10 10
Device Damaged Prior to Receipt by User 10 10
Mechanical Jam 9 9
Migration or Expulsion of Device 9 9
Activation Failure 9 9
Component Missing 9 9
Off-Label Use 8 8
Failure to Osseointegrate 8 8
Unsealed Device Packaging 8 8
Connection Problem 7 7
Manufacturing, Packaging or Shipping Problem 7 7
Expiration Date Error 6 6
Positioning Failure 6 6
Deformation Due to Compressive Stress 6 6
Nonstandard Device 6 6
Material Fragmentation 6 6

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 1496 3385
Insufficient Information 972 2847
Medical device site infection 580 580
Pain 528 619
Failure of Implant 522 535
Joint Laxity 293 2076
Inadequate Osseointegration 289 289
No Clinical Signs, Symptoms or Conditions 242 244
Joint Dislocation 205 1958
Ambulation or Postural Difficulties 193 195
Injury 152 152
Fall 146 146
Bone Fracture(s) 142 1896
Loss of Range of Motion 107 271
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 98 98
No Code Available 96 96
Swelling/ Edema 65 67
Implant Pain 65 67
Cancer 64 64
Aseptic loosening 61 1948
Unequal Limb Length 59 60
No Information 59 59
Scar Tissue 57 59
Metal Related Pathology 54 55
Periprosthetic fracture 45 223
Unspecified Tissue Injury 41 41
Inflammation 40 43
No Known Impact Or Consequence To Patient 36 36
Adhesion(s) 34 34
Hematoma 32 95
Hyperextension 32 32
Fluid Discharge 28 29
Wound Dehiscence 28 29
Osteolysis 24 210
Muscle/Tendon Damage 22 23
Foreign Body Reaction 20 20
Muscular Rigidity 20 21
Bacterial Infection 19 20
Hypersensitivity/Allergic reaction 19 21
Septic loosening 16 16
Synovitis 15 16
Limb Pain 14 14
Osteopenia/ Osteoporosis 13 13
Extraskeletal ossification 12 12
Joint Disorder 12 12
Joint Contracture 12 12
Wound Infection 11 11
Fever 11 11
Swelling 10 10
Hemorrhage/Blood Loss/Bleeding 10 11

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
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