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)
2020	2021	2022	2023	2024	2025
2	1	3	1	4	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	798	1123
Device Dislodged or Dislocated	162	179
Fracture	155	155
Patient Device Interaction Problem	150	150
Loosening of Implant Not Related to Bone-Ingrowth	142	156
Insufficient Information	78	78
Material Integrity Problem	50	50
Naturally Worn	47	47
Mechanical Problem	37	37
Unintended Movement	31	31
Unstable	26	26
Appropriate Term/Code Not Available	25	25
Break	22	22
Migration	18	18
Manufacturing, Packaging or Shipping Problem	12	12
Use of Device Problem	12	12
Degraded	9	9
Malposition of Device	8	8
Noise, Audible	7	7
Tear, Rip or Hole in Device Packaging	7	7
No Apparent Adverse Event	6	6
Packaging Problem	6	6
Device Contaminated During Manufacture or Shipping	6	6
Delivered as Unsterile Product	4	4
Inadequacy of Device Shape and/or Size	4	4
Loose or Intermittent Connection	4	4
Biocompatibility	4	4
Scratched Material	3	3
Off-Label Use	3	3
No Device Output	3	3
Shipping Damage or Problem	2	2
Problem with Sterilization	2	2
Failure to Osseointegrate	2	2
Patient-Device Incompatibility	2	2
Difficult to Open or Remove Packaging Material	2	2
Migration or Expulsion of Device	2	2
Device Appears to Trigger Rejection	2	2
Improper or Incorrect Procedure or Method	2	2
Material Fragmentation	1	1
Material Discolored	1	1
Structural Problem	1	1
Positioning Problem	1	1
Misassembly by Users	1	1
Unsealed Device Packaging	1	1
Labelling, Instructions for Use or Training Problem	1	1
Product Quality Problem	1	1
Detachment of Device or Device Component	1	1
Output Problem	1	1
Separation Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	435	474
Insufficient Information	413	413
Failure of Implant	265	270
Joint Dislocation	147	164
No Clinical Signs, Symptoms or Conditions	104	121
Swelling/ Edema	69	90
No Information	62	62
Loss of Range of Motion	50	50
Unspecified Infection	41	41
Arthritis	37	39
Bone Fracture(s)	36	36
Ambulation Difficulties	32	32
No Known Impact Or Consequence To Patient	27	27
Joint Laxity	24	24
Fall	21	22
Swelling	19	19
Synovitis	19	19
No Consequences Or Impact To Patient	16	16
Discomfort	15	18
Thrombosis/Thrombus	15	171
Impaired Healing	15	21
Metal Related Pathology	14	14
Edema	14	14
Osteolysis	12	12
Osteopenia/ Osteoporosis	10	10
Cramp(s) /Muscle Spasm(s)	10	10
Post Operative Wound Infection	10	34
Hypersensitivity/Allergic reaction	10	10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	10	10
Damage to Ligament(s)	10	10
Cyst(s)	9	9
Scar Tissue	9	9
No Code Available	8	8
Foreign Body In Patient	8	8
Hematoma	7	7
Hemorrhage/Bleeding	6	6
Inadequate Osseointegration	6	6
Death	6	6
Wound Dehiscence	6	6
Joint Swelling	6	6
Tissue Breakdown	6	6
Loss of Vision	4	4
Subluxation	4	4
Hyperextension	4	4
Peripheral Nervous Injury	4	7
Implant Pain	4	4
Skin Inflammation/ Irritation	4	4
Fatigue	4	4
No Patient Involvement	3	3
Rash	3	3