Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 9
2022 9 9
2023 12 12
2024 25 25
2025 8 781

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 25 798
Loosening of Implant Not Related to Bone-Ingrowth 13 602
Fracture 11 719
Break 7 8
Migration or Expulsion of Device 5 6
Malposition of Device 4 253
Device Dislodged or Dislocated 3 527
Naturally Worn 3 3
Biocompatibility 3 3
Material Erosion 2 710
Degraded 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
Improper or Incorrect Procedure or Method 1 185
Osseointegration Problem 1 185
Loss of or Failure to Bond 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Failure of Implant 24 25
Pain 21 730
Insufficient Information 12 785
Unspecified Infection 8 781
Loss of Range of Motion 7 531
Implant Pain 5 5
Osteolysis 5 713
Joint Dislocation 4 777
Arthralgia 3 3
Inadequate Osseointegration 3 3
Joint Laxity 3 711
Deformity/ Disfigurement 3 776
Ambulation Difficulties 3 4
Hypersensitivity/Allergic reaction 2 2
Sepsis 2 2
Metal Related Pathology 2 2
Cellulitis 2 2
Discomfort 2 2
Anxiety 2 3
Swelling/ Edema 2 2
Inadequate Pain Relief 2 2
Arthritis 2 526
No Clinical Signs, Symptoms or Conditions 1 1
Necrosis 1 185
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

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