TPLC - Total Product Life Cycle

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Device	prosthesis, knee, femorotibial, unicompartmental/unicondylar, uncemented, porous-coated, metal/polymer
Regulation Description	Knee joint femorotibial (uni-compartmental) metal/polymer porous-coated uncemented prosthesis.
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	64	64
Failure to Osseointegrate	13	13
Loosening of Implant Not Related to Bone-Ingrowth	7	7
Fracture	6	6
Malposition of Device	5	5
Positioning Problem	5	5
Osseointegration Problem	4	4
Migration	4	4
Off-Label Use	3	3
Detachment of Device or Device Component	2	2
Crack	2	2
Loss of Osseointegration	2	2
Biocompatibility	1	1
Deformation Due to Compressive Stress	1	1
Device Dislodged or Dislocated	1	1
Installation-Related Problem	1	1
Flaked	1	1
Material Fragmentation	1	1
Premature Separation	1	1
Improper or Incorrect Procedure or Method	1	1
Mechanical Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	58	58
Failure of Implant	20	20
Inadequate Osseointegration	20	20
Arthralgia	20	20
Insufficient Information	12	12
Bone Fracture(s)	8	8
Deformity/ Disfigurement	7	7
Discomfort	6	6
Unspecified Tissue Injury	5	5
No Clinical Signs, Symptoms or Conditions	5	5
Joint Dislocation	4	4
Hemorrhage/Bleeding	3	3
Joint Laxity	3	3
Implant Pain	3	3
Foreign Body In Patient	3	3
Perforation	3	3
Loss of Range of Motion	3	3
Abscess	2	2
Erosion	2	2
Device Embedded In Tissue or Plaque	2	2
Ambulation Difficulties	2	2
Inflammation	1	1
Metal Related Pathology	1	1
Swelling/ Edema	1	1