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

MDR Year MDR Reports MDR Events
2020 6 6
2021 8 8
2022 9 9
2023 12 12
2024 25 25
2025 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 21 21
Loosening of Implant Not Related to Bone-Ingrowth 10 10
Fracture 9 9
Break 6 6
Migration or Expulsion of Device 5 5
Naturally Worn 3 3
Biocompatibility 3 3
Malposition of Device 2 2
Degraded 2 2
Device Dislodged or Dislocated 2 2
Noise, Audible 2 2
Output Problem 1 1
Crack 1 1
Insufficient Information 1 1
Defective Device 1 1
Patient Device Interaction Problem 1 1
Material Separation 1 1
Detachment of Device or Device Component 1 1
Appropriate Term/Code Not Available 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
Failure of Implant 22 22
Pain 19 19
Insufficient Information 9 9
Unspecified Infection 5 5
Loss of Range of Motion 4 4
Arthralgia 3 3
Inadequate Osseointegration 3 3
Implant Pain 3 3
Osteolysis 3 3
Ambulation Difficulties 3 3
Hypersensitivity/Allergic reaction 2 2
Sepsis 2 2
Metal Related Pathology 2 2
Cellulitis 2 2
Discomfort 2 2
Anxiety 2 2
Inadequate Pain Relief 2 2
Joint Dislocation 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Bone Fracture(s) 1 1
Muscle Weakness 1 1
Synovitis 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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