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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 25 25

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 20 20
Loosening of Implant Not Related to Bone-Ingrowth 12 12
Fracture 9 9
Break 6 6
Migration or Expulsion of Device 5 5
Naturally Worn 5 5
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
Device Dislodged or Dislocated 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
Connection Problem 1 1
Loss of or Failure to Bond 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 27 27
Failure of Implant 24 24
Insufficient Information 9 9
Inadequate Pain Relief 6 6
Unspecified Infection 6 6
Loss of Range of Motion 4 4
Arthralgia 3 3
Osteolysis 3 3
Implant Pain 3 3
Inadequate Osseointegration 3 3
Metal Related Pathology 2 2
Ambulation Difficulties 2 2
Hypersensitivity/Allergic reaction 2 2
Anxiety 2 2
Discomfort 2 2
Injury 2 2
Muscle Weakness 1 1
Joint Swelling 1 1
Joint Dislocation 1 1
Sepsis 1 1
Synovitis 1 1
Adhesion(s) 1 1
Cellulitis 1 1
Edema 1 1
Fall 1 1
Foreign Body Reaction 1 1
Bone Fracture(s) 1 1
No Code Available 1 1
Subluxation 1 1
Joint Laxity 1 1
No Clinical Signs, Symptoms or Conditions 1 1

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