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	59	59
Failure to Osseointegrate	11	11
Loosening of Implant Not Related to Bone-Ingrowth	7	7
Fracture	6	6
Positioning Problem	5	5
Malposition of Device	5	5
Migration	4	4
Off-Label Use	3	3
Crack	2	2
Detachment of Device or Device Component	2	2
Osseointegration Problem	2	2
Material Fragmentation	1	1
Installation-Related Problem	1	1
Premature Separation	1	1
Mechanical Problem	1	1
Device Dislodged or Dislocated	1	1
Flaked	1	1
Deformation Due to Compressive Stress	1	1
Improper or Incorrect Procedure or Method	1	1
Biocompatibility	1	1
Loss of Osseointegration	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	54	54
Arthralgia	20	20
Failure of Implant	19	19
Inadequate Osseointegration	19	19
Insufficient Information	9	9
Bone Fracture(s)	8	8
Deformity/ Disfigurement	7	7
Discomfort	6	6
No Clinical Signs, Symptoms or Conditions	5	5
Unspecified Tissue Injury	5	5
Joint Dislocation	4	4
Perforation	3	3
Implant Pain	3	3
Foreign Body In Patient	3	3
Joint Laxity	3	3
Hemorrhage/Bleeding	3	3
Abscess	2	2
Erosion	2	2
Ambulation Difficulties	2	2
Device Embedded In Tissue or Plaque	2	2
Metal Related Pathology	1	1
Inflammation	1	1
Loss of Range of Motion	1	1
Swelling/ Edema	1	1