TPLC - Total Product Life Cycle

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Device	prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Definition	This type of device is designed to allow for motion between the plastic bearing and metal baseplate components of a knee prosthesis. It is intended to replace a knee joint in order to relieve pain and restore knee function, for indications such as osteoarthritis, inflammatory arthritis, traumatic arthritis, and revision of failed knee prostheses.
Product Code	NJL
Device Class	3

Premarket Approvals (PMA)
2021	2022	2023	2024	2025	2026
18	30	17	23	23	6

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	6681	6741
Loss of or Failure to Bond	1069	1088
Naturally Worn	431	436
Migration	215	222
Osseointegration Problem	208	211
Unintended Movement	139	140
Device Dislodged or Dislocated	119	122
Device Contaminated During Manufacture or Shipping	97	97
Fracture	83	83
Difficult to Open or Remove Packaging Material	69	69
Use of Device Problem	50	50
Off-Label Use	48	48
Noise, Audible	47	50
Appropriate Term/Code Not Available	39	40
No Apparent Adverse Event	37	37
Tear, Rip or Hole in Device Packaging	37	37
Difficult to Insert	32	32
Insufficient Information	16	16
Improper or Incorrect Procedure or Method	14	14
Patient Device Interaction Problem	14	14
Break	12	13
Device Damaged Prior to Use	11	11
Difficult to Advance	10	10
Patient-Device Incompatibility	10	12
Device-Device Incompatibility	9	10
Loosening of Implant Not Related to Bone-Ingrowth	7	11
Expiration Date Error	7	7
Incorrect Measurement	7	9
Inaccurate Information	5	6
Inadequacy of Device Shape and/or Size	4	4
Illegible Information	3	3
Corroded	3	3
Incomplete or Missing Packaging	3	3
Unstable	3	3
Degraded	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Defective Device	2	2
Computer Software Problem	2	2
Loss of Osseointegration	2	2
Material Integrity Problem	1	1
Shipping Damage or Problem	1	1
Material Deformation	1	1
Packaging Problem	1	1
Material Erosion	1	1
Detachment of Device or Device Component	1	1
Missing Information	1	1
Device Markings/Labelling Problem	1	1
Malposition of Device	1	1
Entrapment of Device	1	1
Nonstandard Device	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	2874	2933
Unspecified Infection	2171	2184
Joint Laxity	1928	1963
Insufficient Information	1131	1140
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	653	655
Swelling/ Edema	529	560
Loss of Range of Motion	499	517
Adhesion(s)	493	500
Muscular Rigidity	437	443
Fall	317	321
Unspecified Tissue Injury	243	250
No Clinical Signs, Symptoms or Conditions	236	239
Synovitis	221	228
Inadequate Osseointegration	209	213
Osteolysis	174	180
Ambulation Difficulties	155	175
Discomfort	145	153
Bone Fracture(s)	119	122
Inflammation	111	117
Wound Dehiscence	111	112
Joint Dislocation	98	101
Unspecified Musculoskeletal problem	90	92
Hemorrhage/Bleeding	67	68
Foreign Body Reaction	64	65
Fluid Discharge	60	60
Thrombosis/Thrombus	58	58
Hypersensitivity/Allergic reaction	55	57
Joint Contracture	53	54
Fatigue	44	51
Erythema	44	44
Scar Tissue	42	44
Muscle/Tendon Damage	42	43
Hematoma	38	38
Pulmonary Embolism	37	37
Cyst(s)	35	35
Impaired Healing	35	35
Sepsis	27	28
Fibrosis	26	26
Necrosis	25	25
Ossification	24	24
Fever	23	23
Abscess	20	20
Nerve Damage	19	19
Post Operative Wound Infection	15	15
Cellulitis	13	13
Failure of Implant	12	16
Anemia	11	11
Low Blood Pressure/ Hypotension	10	10
Numbness	10	10
Physical Asymmetry	10	11