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)
2009	2010	2011	2012	2013	2014	2015	2016	2017	2018	2019	2020	2021	2022	2023	2024
0	3	6	5	8	2	4	6	8	14	12	2	1	3	1	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Insufficient Information	1298	1298
Adverse Event Without Identified Device or Use Problem	754	754
Device Dislodged or Dislocated	443	443
Appropriate Term/Code Not Available	259	259
Migration or Expulsion of Device	212	212
Loose or Intermittent Connection	212	212
Fracture	203	203
Patient Device Interaction Problem	151	151
Unstable	125	125
Loosening of Implant Not Related to Bone-Ingrowth	115	120
Device Slipped	97	97
Break	62	62
Mechanical Problem	59	59
Naturally Worn	55	55
Material Integrity Problem	53	53
Malposition of Device	43	43
Noise, Audible	36	36
Unintended Movement	35	35
Migration	34	34
Loss of or Failure to Bond	29	29
Device Operates Differently Than Expected	28	28
Inadequacy of Device Shape and/or Size	19	19
Packaging Problem	17	17
Material Erosion	16	16
Use of Device Problem	14	14
Degraded	14	14
Manufacturing, Packaging or Shipping Problem	13	13
Detachment Of Device Component	12	12
Tear, Rip or Hole in Device Packaging	12	12
Off-Label Use	8	8
Metal Shedding Debris	8	8
Positioning Problem	8	8
Improper or Incorrect Procedure or Method	7	7
Collapse	7	7
Device Markings/Labelling Problem	7	7
Scratched Material	6	6
Unsealed Device Packaging	6	6
Detachment of Device or Device Component	5	5
Delivered as Unsterile Product	5	5
Material Separation	4	4
Device Contaminated During Manufacture or Shipping	4	4
Fitting Problem	4	4
Material Fragmentation	4	4
Device Packaging Compromised	4	4
Entrapment of Device	3	3
Difficult to Open or Remove Packaging Material	3	3
Missing Information	3	3
Material Deformation	3	3
Material Rupture	3	3
Failure to Osseointegrate	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	1147	1147
No Information	840	840
No Code Available	568	568
Joint Dislocation	330	330
Insufficient Information	285	285
Failure of Implant	224	229
Unspecified Infection	215	215
Bone Fracture(s)	169	169
Swelling	111	111
No Known Impact Or Consequence To Patient	105	105
Ambulation Difficulties	104	104
Loss of Range of Motion	82	82
Death	80	80
No Clinical Signs, Symptoms or Conditions	79	79
Arthritis	72	72
Swelling/ Edema	60	60
Fall	51	51
No Consequences Or Impact To Patient	45	45
Synovitis	36	36
Limited Mobility Of The Implanted Joint	33	33
Damage to Ligament(s)	32	32
Osteolysis	24	24
Inflammation	22	22
Patient Problem/Medical Problem	21	21
Edema	20	20
Reaction	20	20
Discomfort	20	20
Hematoma	19	19
Wound Dehiscence	18	18
No Patient Involvement	17	17
Necrosis	17	17
Cyst(s)	17	17
Joint Laxity	16	16
Foreign Body In Patient	16	16
Scar Tissue	14	14
Joint Swelling	13	13
Hypersensitivity/Allergic reaction	13	13
Sleep Dysfunction	13	13
Pulmonary Embolism	13	13
Metal Related Pathology	11	11
Hemorrhage/Bleeding	11	11
Collapse	11	11
Osteopenia/ Osteoporosis	10	10
Cramp(s) /Muscle Spasm(s)	10	10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	10	10
Adhesion(s)	9	9
Tissue Damage	8	8
Tissue Breakdown	8	8
Device Embedded In Tissue or Plaque	8	8
Numbness	7	7