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	7

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	896	1236
Device Dislodged or Dislocated	172	190
Fracture	169	170
Loosening of Implant Not Related to Bone-Ingrowth	162	176
Patient Device Interaction Problem	129	138
Naturally Worn	58	58
Material Integrity Problem	31	32
Mechanical Problem	26	26
Unstable	25	25
Unintended Movement	23	23
Insufficient Device Problem Information	19	20
Migration	17	17
Implant subsidence	17	35
Break	13	13
Malposition of Device	11	11
Use of Device Problem	10	10
Device Contaminated During Manufacture or Shipping	8	8
Appropriate Device Problem Term/Code Not Available	8	8
Degraded	8	8
Tear, Rip or Hole in Device Packaging	8	8
Noise, Audible	6	6
No Apparent Adverse Event	6	6
Inadequacy of Device Shape and/or Size	6	6
Biocompatibility	4	4
Packaging Problem	4	4
Manufacturing, Packaging or Shipping Problem	4	4
Off-Label Use	4	4
Delivered as Unsterile Product	3	3
Scratched Material	3	3
Failure to Osseointegrate	2	2
Unsealed Device Packaging	2	2
Improper or Incorrect Procedure or Method	2	2
Migration or Expulsion of Device	2	2
Structural Problem	1	1
Misassembly by Users	1	1
Material Discolored	1	1
Material Fragmentation	1	1
Positioning Problem	1	1
Labelling, Instructions for Use or Training Problem	1	1
Device Damaged Prior to Receipt by User	1	1
Detachment of Device or Device Component	1	1
Patient-Device Incompatibility	1	1
Device Appears to Trigger Rejection	1	1
Separation Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Insufficient Information	472	486
Pain	408	453
Failure of Implant	262	272
Joint Dislocation	161	180
No Clinical Signs, Symptoms or Conditions	123	140
Swelling/ Edema	70	94
Loss of Range of Motion	55	60
Aseptic loosening	49	58
Joint Laxity	46	46
Bone Fracture(s)	42	42
Unspecified Infection	40	40
Periprosthetic fracture	37	41
Ambulation or Postural Difficulties	34	35
Arthritis	28	33
Medical device site infection	25	26
Fall	20	21
Synovitis	20	21
Radiolucent Lines	19	57
Hematoma	18	18
Impaired Healing	17	27
Joint effusion	16	16
Hemarthrosis	16	25
Thrombosis/Thrombus	15	171
Metal Related Pathology	14	14
No Information	13	13
Osteolysis	13	13
Post Operative Wound Infection	13	37
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	10	10
Damage to Ligament(s)	10	10
Cramp(s) /Muscle Spasm(s)	10	10
Osteopenia/ Osteoporosis	10	10
Hypersensitivity/Allergic reaction	10	13
Foreign Body In Patient	9	9
Wound Dehiscence	9	9
Scar Tissue	9	9
Joint Impingement	8	8
Discomfort	8	11
Tissue Breakdown	6	6
Bacterial Infection	6	6
Muscle/Tendon Damage	6	6
Hemorrhage/Blood Loss/Bleeding	6	6
Inadequate Osseointegration	6	6
Cyst(s)	6	6
Skin Inflammation/ Irritation	4	4
Peripheral Nervous Injury	4	7
Hyperextension	4	4
Subluxation	4	4
Implant Pain	4	4
Fatigue	4	4
Loss of Vision	4	4