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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
Device prosthesis, knee, patello/femoral, semi-constrained, cemented, metal/polymer
Product CodeKRR
Regulation Number 888.3540
Device Class 2


Premarket Reviews
ManufacturerDecision
ARTHROSURFACE, INC.
  SUBSTANTIALLY EQUIVALENT 1
EPISURF MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
HOWMEDICA OSTEONICS CORP., DBA STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 14 14
2019 15 15
2020 6 6
2021 8 8
2022 9 9
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Loose or Intermittent Connection 8 8
Insufficient Information 7 7
Loosening of Implant Not Related to Bone-Ingrowth 7 7
Migration or Expulsion of Device 6 6
Fracture 6 6
Adverse Event Without Identified Device or Use Problem 6 6
Naturally Worn 5 5
Break 4 4
Unstable 3 3
Appropriate Term/Code Not Available 3 3
Noise, Audible 3 3
Patient-Device Incompatibility 2 2
Biocompatibility 2 2
Connection Problem 1 1
Detachment of Device or Device Component 1 1
Difficult to Open or Remove Packaging Material 1 1
Device Dislodged or Dislocated 1 1
Loss of or Failure to Bond 1 1
Output Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Loss of Osseointegration 1 1
Material Separation 1 1
Crack 1 1
Degraded 1 1
Material Fragmentation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 25 25
Failure of Implant 11 11
Inadequate Pain Relief 6 6
No Code Available 4 4
Unspecified Infection 4 4
Loss of Range of Motion 4 4
Swelling 4 4
Injury 4 4
Ambulation Difficulties 3 3
Osteolysis 3 3
Metal Related Pathology 2 2
Implant Pain 2 2
Anxiety 2 2
Edema 2 2
Erythema 1 1
Bone Fracture(s) 1 1
Hematoma 1 1
Hypersensitivity/Allergic reaction 1 1
Muscle Weakness 1 1
Adhesion(s) 1 1
Arthritis 1 1
Arthralgia 1 1
Joint Swelling 1 1
Joint Dislocation 1 1
Synovitis 1 1
Discomfort 1 1
Subluxation 1 1
Joint Laxity 1 1
Inadequate Osseointegration 1 1
Fluid Discharge 1 1
Patient Problem/Medical Problem 1 1
No Known Impact Or Consequence To Patient 1 1
No Information 1 1
Insufficient Information 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
2 Zimmer Biomet, Inc. II Mar-14-2018
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