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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 25 798
Patient Device Interaction Problem 23 23
Loosening of Implant Not Related to Bone-Ingrowth 16 606
Fracture 8 718
Break 7 9
Malposition of Device 4 253
Biocompatibility 3 3
Improper or Incorrect Procedure or Method 3 187
Device Dislodged or Dislocated 3 527
Naturally Worn 3 3
Noise, Audible 2 3
Migration or Expulsion of Device 2 3
Degraded 2 2
Material Erosion 2 710
Crack 1 1
Defective Device 1 1
Connection Problem 1 1
Detachment of Device or Device Component 1 2
Osseointegration Problem 1 185
Output Problem 1 1
Insufficient Information 1 1
Appropriate Term/Code Not Available 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 Dislocation 4 777
Arthralgia 3 3
Inadequate Osseointegration 3 3
Deformity/ Disfigurement 3 776
Arthritis 3 527
Hypersensitivity/Allergic reaction 2 2
Sepsis 2 2
Metal Related Pathology 2 2
Cellulitis 2 2
Discomfort 2 2
Osteolysis 2 710
Scar Tissue 2 2
Muscle/Tendon Damage 2 2
Anxiety 2 3
Joint Laxity 2 710
Ambulation Difficulties 2 3
No Clinical Signs, Symptoms or Conditions 1 1
Necrosis 1 185
Muscle Weakness 1 1
Foreign Body Reaction 1 1
Numbness 1 1
Fall 1 1
Subluxation 1 1
Inadequate Pain Relief 1 1

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