TPLC - Total Product Life Cycle

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Device	prosthesis, knee, femorotibial, unicompartmental/unicondylar, uncemented, porous-coated, metal/polymer
Definition	Intended to replace part of a knee joint in order to relieve pain and restore knee function, for indications such as uni-compartmental osteoarthritis; inflammatory arthritis; traumatic arthritis; varus, valgus or flexion deformities; and revision surgery.
Product Code	NJD
Regulation Number	888.3535
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	56	56
Failure to Osseointegrate	10	10
Fracture	6	6
Malposition of Device	5	5
Positioning Problem	5	5
Migration	4	4
Loosening of Implant Not Related to Bone-Ingrowth	3	3
Off-Label Use	3	3
Osseointegration Problem	2	2
Detachment of Device or Device Component	2	2
Crack	2	2
Flaked	1	1
Material Fragmentation	1	1
Mechanical Problem	1	1
Deformation Due to Compressive Stress	1	1
Improper or Incorrect Procedure or Method	1	1
Loss of Osseointegration	1	1
Installation-Related Problem	1	1
Premature Separation	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	52	52
Arthralgia	19	19
Failure of Implant	17	17
Inadequate Osseointegration	15	15
Insufficient Information	9	9
Deformity/ Disfigurement	6	6
Discomfort	6	6
Bone Fracture(s)	5	5
Unspecified Tissue Injury	5	5
No Clinical Signs, Symptoms or Conditions	5	5
Joint Dislocation	4	4
Foreign Body In Patient	3	3
Perforation	3	3
Joint Laxity	3	3
Hemorrhage/Bleeding	2	2
Abscess	2	2
Erosion	2	2
Device Embedded In Tissue or Plaque	2	2
Implant Pain	2	2
Ambulation Difficulties	2	2