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	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	674	674
Patient Device Interaction Problem	150	150
Device Dislodged or Dislocated	141	141
Fracture	140	140
Loosening of Implant Not Related to Bone-Ingrowth	127	132
Insufficient Information	78	78
Material Integrity Problem	50	50
Mechanical Problem	37	37
Naturally Worn	31	31
Unintended Movement	30	30
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	7	7
Noise, Audible	7	7
Packaging Problem	6	6
Tear, Rip or Hole in Device Packaging	6	6
No Apparent Adverse Event	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
Patient-Device Incompatibility	2	2
Shipping Damage or Problem	2	2
Problem with Sterilization	2	2
Failure to Osseointegrate	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
Unsealed Device Packaging	1	1
Positioning Problem	1	1
Material Fragmentation	1	1
Output Problem	1	1
Structural Problem	1	1
Misassembly by Users	1	1
Labelling, Instructions for Use or Training Problem	1	1
Product Quality Problem	1	1
Detachment of Device or Device Component	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	407	407
Insufficient Information	380	380
Failure of Implant	265	270
Joint Dislocation	126	126
No Clinical Signs, Symptoms or Conditions	91	91
Swelling/ Edema	63	63
No Information	62	62
Loss of Range of Motion	47	47
Unspecified Infection	40	40
Arthritis	33	33
Ambulation Difficulties	31	31
Bone Fracture(s)	31	31
No Known Impact Or Consequence To Patient	27	27
Joint Laxity	21	21
Fall	19	19
Swelling	19	19
Synovitis	17	17
No Consequences Or Impact To Patient	16	16
Metal Related Pathology	14	14
Edema	14	14
Discomfort	12	12
Osteolysis	11	11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	10	10
Hypersensitivity/Allergic reaction	10	10
Osteopenia/ Osteoporosis	10	10
Cramp(s) /Muscle Spasm(s)	10	10
Damage to Ligament(s)	9	9
Scar Tissue	9	9
Foreign Body In Patient	9	9
No Code Available	8	8
Cyst(s)	8	8
Hematoma	7	7
Post Operative Wound Infection	7	7
Tissue Breakdown	6	6
Hemorrhage/Bleeding	6	6
Joint Swelling	6	6
Inadequate Osseointegration	6	6
Wound Dehiscence	6	6
Death	6	6
Implant Pain	4	4
Skin Inflammation/ Irritation	4	4
Hyperextension	4	4
Subluxation	4	4
Fatigue	4	4
Loss of Vision	4	4
No Patient Involvement	3	3
Rash	3	3
Cellulitis	3	3
Inflammation	3	3
Muscle/Tendon Damage	3	3