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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
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
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 1
OVERTURE RESURFACING INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 15 15
2020 6 6
2021 8 8
2022 9 9
2023 12 12
2024 18 18

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 17 17
Loosening of Implant Not Related to Bone-Ingrowth 12 12
Fracture 9 9
Migration or Expulsion of Device 5 5
Naturally Worn 5 5
Break 4 4
Loose or Intermittent Connection 4 4
Unstable 3 3
Insufficient Information 3 3
Appropriate Term/Code Not Available 3 3
Biocompatibility 3 3
Noise, Audible 3 3
Malposition of Device 2 2
Output Problem 1 1
Crack 1 1
Patient-Device Incompatibility 1 1
Defective Device 1 1
Patient Device Interaction Problem 1 1
Degraded 1 1
Material Fragmentation 1 1
Material Separation 1 1
Detachment of Device or Device Component 1 1
Device Dislodged or Dislocated 1 1
Connection Problem 1 1
Loss of or Failure to Bond 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 26 26
Failure of Implant 21 21
Unspecified Infection 6 6
Insufficient Information 6 6
Inadequate Pain Relief 6 6
Loss of Range of Motion 4 4
Arthralgia 3 3
Inadequate Osseointegration 3 3
Implant Pain 3 3
Osteolysis 3 3
Hypersensitivity/Allergic reaction 2 2
Metal Related Pathology 2 2
Injury 2 2
Discomfort 2 2
Anxiety 2 2
Ambulation Difficulties 2 2
Joint Dislocation 1 1
Sepsis 1 1
No Code Available 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Adhesion(s) 1 1
Bone Fracture(s) 1 1
Muscle Weakness 1 1
Synovitis 1 1
Edema 1 1
Cellulitis 1 1
Foreign Body Reaction 1 1
Joint Swelling 1 1
Fall 1 1
Subluxation 1 1
Joint Laxity 1 1

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