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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, knee, patello/femoral, semi-constrained, cemented, metal/polymer
Regulation Description Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis.
Product CodeKRR
Regulation Number 888.3540
Device Class 2


Premarket Reviews
ManufacturerDecision
EPISURF MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
HOWMEDICA OSTEONICS CORP., DBA STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1
OVERTURE RESURFACING, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 8 9
2022 9 11
2023 12 12
2024 25 26
2025 36 809
2026 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 24 797
Patient Device Interaction Problem 23 23
Loosening of Implant Not Related to Bone-Ingrowth 13 603
Fracture 8 718
Break 5 5
Malposition of Device 4 253
Device Dislodged or Dislocated 3 527
Biocompatibility 3 3
Improper or Incorrect Procedure or Method 3 187
Material Erosion 2 710
Degraded 2 2
Noise, Audible 1 2
Migration or Expulsion of Device 1 1
Detachment of Device or Device Component 1 2
Connection Problem 1 1
Crack 1 1
Osseointegration Problem 1 185
Defective Device 1 1
Loss of or Failure to Bond 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 38 748
Failure of Implant 28 31
Insufficient Information 14 787
Unspecified Infection 11 784
Swelling/ Edema 10 10
Loss of Range of Motion 8 533
Implant Pain 5 6
Joint effusion 4 5
Joint Dislocation 4 777
Aseptic loosening 3 776
Arthritis 3 527
Inadequate Osseointegration 3 3
Arthralgia 3 3
Deformity/ Disfigurement 3 776
Metal Related Pathology 2 2
Cellulitis 2 2
Joint Laxity 2 710
Scar Tissue 2 2
Periprosthetic fracture 2 710
Sepsis 2 2
Hypersensitivity/Allergic reaction 2 2
Anxiety 2 3
Ambulation or Postural Difficulties 2 3
Muscle/Tendon Damage 2 2
Osteolysis 2 710
Discomfort 2 2
Foreign Body Reaction 1 1
Necrosis 1 185
Muscle Weakness/Atrophy 1 1
Numbness 1 1
Subluxation 1 1
High metal ion levels 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Inadequate Pain Relief 1 1
Crepitus 1 1
Fall 1 1

Recalls
Manufacturer Recall Class Date Posted
1 MEDLINE INDUSTRIES, LP - Northfield II Feb-01-2023
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