TPLC - Total Product Life Cycle

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Device	prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
Definition	This type of device is designed to allow for motion between the plastic tibial bearing and metal tibial baseplate components of a unicompartmental knee prosthesis. It is intended to replace part of a knee joint in order to relieve pain and restore knee function, for indications such as osteoarthritis and avascular necrosis.
Product Code	NRA
Device Class	3

Premarket Approvals (PMA)
2019	2020	2021	2022	2023	2024
12	2	1	3	1	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	616	616
Insufficient Information	296	296
Patient Device Interaction Problem	151	151
Device Dislodged or Dislocated	147	147
Fracture	116	116
Loosening of Implant Not Related to Bone-Ingrowth	115	120
Appropriate Term/Code Not Available	92	92
Loose or Intermittent Connection	60	60
Break	50	50
Material Integrity Problem	50	50
Mechanical Problem	38	38
Migration	34	34
Unintended Movement	30	30
Unstable	29	29
Naturally Worn	22	22
Noise, Audible	14	14
Manufacturing, Packaging or Shipping Problem	12	12
Use of Device Problem	12	12
Tear, Rip or Hole in Device Packaging	10	10
Degraded	9	9
Malposition of Device	9	9
Packaging Problem	8	8
Unsealed Device Packaging	5	5
Inadequacy of Device Shape and/or Size	5	5
Delivered as Unsterile Product	4	4
Device Contaminated During Manufacture or Shipping	4	4
Scratched Material	3	3
Collapse	3	3
Device Markings/Labelling Problem	3	3
No Device Output	3	3
Material Twisted/Bent	3	3
Fitting Problem	3	3
Off-Label Use	3	3
Difficult to Open or Remove Packaging Material	3	3
Missing Information	3	3
Patient-Device Incompatibility	2	2
Biocompatibility	2	2
Mechanical Jam	2	2
Problem with Sterilization	2	2
Failure to Osseointegrate	2	2
Improper or Incorrect Procedure or Method	2	2
Device Appears to Trigger Rejection	2	2
Migration or Expulsion of Device	2	2
Inaccurate Delivery	2	2
Component Incompatible	1	1
Detachment of Device or Device Component	1	1
Product Quality Problem	1	1
Labelling, Instructions for Use or Training Problem	1	1
Misassembly by Users	1	1
Pitted	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	476	476
No Information	307	307
Insufficient Information	285	285
Failure of Implant	207	212
Joint Dislocation	144	144
No Clinical Signs, Symptoms or Conditions	79	79
No Code Available	75	75
Swelling/ Edema	60	60
Bone Fracture(s)	53	53
Loss of Range of Motion	45	45
Unspecified Infection	41	41
Arthritis	40	40
No Known Impact Or Consequence To Patient	38	38
No Consequences Or Impact To Patient	32	32
Ambulation Difficulties	31	31
Swelling	31	31
Fall	18	18
Edema	17	17
Joint Laxity	16	16
Synovitis	16	16
Damage to Ligament(s)	14	14
Discomfort	12	12
Metal Related Pathology	11	11
Cyst(s)	11	11
Osteolysis	10	10
Cramp(s) /Muscle Spasm(s)	10	10
Osteopenia/ Osteoporosis	10	10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	10	10
Hypersensitivity/Allergic reaction	10	10
No Patient Involvement	9	9
Wound Dehiscence	9	9
Hematoma	8	8
Scar Tissue	8	8
Inflammation	6	6
Tissue Breakdown	6	6
Hemorrhage/Bleeding	6	6
Foreign Body In Patient	6	6
Inadequate Osseointegration	6	6
Collapse	6	6
Joint Swelling	6	6
Death	6	6
Pulmonary Embolism	5	5
Implant Pain	4	4
Skin Inflammation/ Irritation	4	4
Loss of Vision	4	4
Fever	4	4
Subluxation	4	4
Fatigue	4	4
High Blood Pressure/ Hypertension	3	3
Impaired Healing	3	3