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	0

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	586	586
Patient Device Interaction Problem	150	150
Device Dislodged or Dislocated	131	131
Fracture	118	118
Loosening of Implant Not Related to Bone-Ingrowth	117	122
Insufficient Information	78	78
Material Integrity Problem	50	50
Mechanical Problem	37	37
Unintended Movement	30	30
Naturally Worn	26	26
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
Noise, Audible	7	7
Tear, Rip or Hole in Device Packaging	6	6
Malposition of Device	6	6
Packaging Problem	6	6
Device Contaminated During Manufacture or Shipping	4	4
Loose or Intermittent Connection	4	4
Inadequacy of Device Shape and/or Size	4	4
Delivered as Unsterile Product	4	4
Off-Label Use	3	3
No Device Output	3	3
Scratched Material	3	3
Device Appears to Trigger Rejection	2	2
Shipping Damage or Problem	2	2
Patient-Device Incompatibility	2	2
Biocompatibility	2	2
Improper or Incorrect Procedure or Method	2	2
Difficult to Open or Remove Packaging Material	2	2
Problem with Sterilization	2	2
Failure to Osseointegrate	2	2
Migration or Expulsion of Device	2	2
Positioning Problem	1	1
Product Quality Problem	1	1
Output Problem	1	1
Unsealed Device Packaging	1	1
Detachment of Device or Device Component	1	1
Material Fragmentation	1	1
Labelling, Instructions for Use or Training Problem	1	1
Misassembly by Users	1	1
Structural Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	393	393
Insufficient Information	315	315
Failure of Implant	227	232
Joint Dislocation	115	115
No Clinical Signs, Symptoms or Conditions	83	83
No Information	62	62
Swelling/ Edema	61	61
Loss of Range of Motion	45	45
Unspecified Infection	37	37
Bone Fracture(s)	31	31
Ambulation Difficulties	31	31
Arthritis	27	27
No Known Impact Or Consequence To Patient	27	27
Joint Laxity	19	19
Swelling	19	19
Fall	17	17
No Consequences Or Impact To Patient	16	16
Edema	14	14
Synovitis	14	14
Discomfort	12	12
Metal Related Pathology	11	11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	10	10
Osteopenia/ Osteoporosis	10	10
Hypersensitivity/Allergic reaction	10	10
Cramp(s) /Muscle Spasm(s)	10	10
Osteolysis	10	10
Damage to Ligament(s)	9	9
Scar Tissue	8	8
Cyst(s)	8	8
No Code Available	8	8
Foreign Body In Patient	8	8
Hematoma	7	7
Wound Dehiscence	6	6
Death	6	6
Tissue Breakdown	6	6
Joint Swelling	6	6
Inadequate Osseointegration	6	6
Hemorrhage/Bleeding	6	6
Fatigue	4	4
Subluxation	4	4
Skin Inflammation/ Irritation	4	4
Loss of Vision	4	4
Implant Pain	4	4
No Patient Involvement	3	3
Inflammation	3	3
High Blood Pressure/ Hypertension	3	3
Cellulitis	3	3
Impaired Healing	3	3
Muscle/Tendon Damage	3	3
Deformity/ Disfigurement	3	3