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)
2019	2020	2021	2022	2023	2024
30	28	18	30	17	16

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	7604	7604
Loss of or Failure to Bond	2015	2015
Naturally Worn	476	476
Migration	327	327
Unintended Movement	216	216
Osseointegration Problem	159	159
Device Dislodged or Dislocated	148	148
Device Contaminated During Manufacture or Shipping	102	102
Fracture	98	98
Loosening of Implant Not Related to Bone-Ingrowth	78	78
Use of Device Problem	76	76
Difficult to Open or Remove Packaging Material	69	69
Loss of Osseointegration	62	62
Noise, Audible	57	57
Appropriate Term/Code Not Available	57	57
Off-Label Use	55	55
Malposition of Device	52	52
Break	42	42
Tear, Rip or Hole in Device Packaging	41	41
No Apparent Adverse Event	40	40
Difficult to Insert	39	39
Material Deformation	34	34
Device-Device Incompatibility	34	34
Material Twisted/Bent	28	28
Inadequacy of Device Shape and/or Size	25	25
Insufficient Information	22	22
Patient Device Interaction Problem	20	20
Patient-Device Incompatibility	18	18
Mechanical Jam	14	14
Loose or Intermittent Connection	13	13
Difficult to Advance	13	13
Device Damaged Prior to Use	12	12
Incorrect Measurement	12	12
Improper or Incorrect Procedure or Method	11	11
Physical Resistance/Sticking	11	11
Migration or Expulsion of Device	11	11
Unstable	10	10
Expiration Date Error	10	10
Contamination /Decontamination Problem	6	6
Inaccurate Information	6	6
Corroded	5	5
Packaging Problem	4	4
Product Quality Problem	4	4
Illegible Information	4	4
Missing Information	4	4
Defective Device	4	4
Difficult to Remove	3	3
Scratched Material	3	3
Incomplete or Missing Packaging	3	3
Fitting Problem	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	4212	4212
No Code Available	3348	3348
Unspecified Infection	2278	2278
Joint Laxity	1716	1716
Insufficient Information	908	908
Adhesion(s)	786	786
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	704	704
Loss of Range of Motion	524	524
Swelling/ Edema	523	523
Muscular Rigidity	497	497
Fall	317	317
Edema	300	300
Synovitis	279	279
Discomfort	241	241
Osteolysis	234	234
Limited Mobility Of The Implanted Joint	219	219
No Clinical Signs, Symptoms or Conditions	217	217
Inadequate Osseointegration	211	211
Ambulation Difficulties	207	207
Unspecified Tissue Injury	187	187
Inflammation	166	166
No Consequences Or Impact To Patient	147	147
Bone Fracture(s)	144	144
Wound Dehiscence	130	130
Joint Dislocation	116	116
Injury	101	101
Hypersensitivity/Allergic reaction	95	95
Unspecified Musculoskeletal problem	87	87
Foreign Body Reaction	82	82
Hemorrhage/Bleeding	82	82
Joint Disorder	75	75
Swelling	70	70
Thrombosis/Thrombus	59	59
Hematoma	55	55
Scar Tissue	53	53
Fatigue	52	52
Cyst(s)	51	51
Fluid Discharge	51	51
Joint Contracture	51	51
Fibrosis	49	49
Erythema	48	48
Pulmonary Embolism	45	45
Necrosis	45	45
Not Applicable	44	44
Muscle/Tendon Damage	42	42
Impaired Healing	38	38
Fever	33	33
Sepsis	33	33
Abscess	28	28
Tissue Damage	23	23