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)
2021	2022	2023	2024	2025	2026
1	3	1	4	3	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	831	1167
Device Dislodged or Dislocated	163	181
Fracture	158	159
Loosening of Implant Not Related to Bone-Ingrowth	153	167
Patient Device Interaction Problem	129	138
Naturally Worn	53	53
Material Integrity Problem	31	32
Mechanical Problem	26	26
Unstable	25	25
Unintended Movement	23	23
Insufficient Information	16	17
Migration	15	15
Break	13	13
Use of Device Problem	11	11
Malposition of Device	10	10
Degraded	8	8
Tear, Rip or Hole in Device Packaging	8	8
Appropriate Term/Code Not Available	8	8
Device Contaminated During Manufacture or Shipping	7	7
No Apparent Adverse Event	6	6
Noise, Audible	6	6
Inadequacy of Device Shape and/or Size	5	5
Manufacturing, Packaging or Shipping Problem	4	4
Packaging Problem	4	4
Biocompatibility	4	4
Scratched Material	3	3
Delivered as Unsterile Product	3	3
Off-Label Use	3	3
Unsealed Device Packaging	2	2
Failure to Osseointegrate	2	2
Migration or Expulsion of Device	2	2
Improper or Incorrect Procedure or Method	2	2
Positioning Problem	1	1
Patient-Device Incompatibility	1	1
Material Fragmentation	1	1
Shipping Damage or Problem	1	1
Output Problem	1	1
Material Discolored	1	1
Structural Problem	1	1
Misassembly by Users	1	1
Labelling, Instructions for Use or Training Problem	1	1
Detachment of Device or Device Component	1	1
Separation Problem	1	1
Device Appears to Trigger Rejection	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Insufficient Information	450	460
Pain	384	429
Failure of Implant	262	272
Joint Dislocation	153	172
No Clinical Signs, Symptoms or Conditions	114	131
Swelling/ Edema	70	94
Loss of Range of Motion	48	49
Joint Laxity	40	40
Bone Fracture(s)	39	39
Unspecified Infection	37	37
Ambulation Difficulties	32	33
Arthritis	28	33
Synovitis	21	22
Fall	20	21
Impaired Healing	16	22
Metal Related Pathology	16	16
Hematoma	16	16
Thrombosis/Thrombus	15	171
No Information	13	13
Osteolysis	13	13
Post Operative Wound Infection	13	37
Damage to Ligament(s)	10	10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	10	10
Hypersensitivity/Allergic reaction	10	13
Osteopenia/ Osteoporosis	10	10
Cramp(s) /Muscle Spasm(s)	10	10
Scar Tissue	9	9
Foreign Body In Patient	9	9
Wound Dehiscence	9	9
Discomfort	8	11
Cyst(s)	6	6
Muscle/Tendon Damage	6	6
Inadequate Osseointegration	6	6
Bacterial Infection	6	6
Hemorrhage/Bleeding	6	6
Tissue Breakdown	6	6
Implant Pain	4	4
Skin Inflammation/ Irritation	4	4
Peripheral Nervous Injury	4	7
Hyperextension	4	4
Subluxation	4	4
Loss of Vision	4	4
No Consequences Or Impact To Patient	4	4
Fatigue	4	4
Rash	3	3
Cellulitis	3	3
Inflammation	3	3
Unspecified Tissue Injury	3	24
Fungal Infection	3	3
Pseudoaneurysm	3	3