TPLC - Total Product Life Cycle

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Device	prosthesis, ankle, uncemented, non-constrained
Definition	An ankle joint metal/polymer non-constrained uncemented prosthesis is a device intended to be implanted to replace an ankle joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a tibial component made of alloys, such as cobalt-chromium-molybdenum, and a talar component made of ultra-high molecular weight polyethylene.
Product Code	NTG
Device Class	3

Premarket Approvals (PMA)
2009	2010	2011	2012	2013	2014	2015	2016	2017	2018	2019	2020	2021	2022	2023	2024
1	2	0	0	2	2	0	2	0	1	3	2	7	4	2	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	728	728
Fracture	137	137
Insufficient Information	123	123
Break	107	107
Appropriate Term/Code Not Available	85	85
Loss of Osseointegration	74	74
Naturally Worn	56	56
Unstable	52	52
Malposition of Device	40	40
Inadequacy of Device Shape and/or Size	29	29
Device Operates Differently Than Expected	26	26
Device Dislodged or Dislocated	25	25
Patient-Device Incompatibility	17	17
Device Slipped	16	16
Loose or Intermittent Connection	14	14
Unintended Movement	14	14
Improper or Incorrect Procedure or Method	12	12
Migration	12	12
Migration or Expulsion of Device	9	9
Material Deformation	8	8
Failure to Align	7	7
Therapeutic or Diagnostic Output Failure	5	5
Degraded	5	5
Collapse	5	5
Failure to Osseointegrate	4	4
Use of Device Problem	4	4
Loss of or Failure to Bond	4	4
Material Integrity Problem	4	4
Entrapment of Device	4	4
Noise, Audible	3	3
Loosening of Implant Not Related to Bone-Ingrowth	3	3
Failure To Adhere Or Bond	3	3
Osseointegration Problem	3	3
Material Twisted/Bent	3	3
Off-Label Use	3	3
Detachment Of Device Component	2	2
Detachment of Device or Device Component	2	2
Material Erosion	2	2
Positioning Problem	2	2
Connection Problem	1	1
Human-Device Interface Problem	1	1
Device Reprocessing Problem	1	1
Loss of Power	1	1
Deformation Due to Compressive Stress	1	1
Bent	1	1
Flaked	1	1
Component Missing	1	1
Material Too Rigid or Stiff	1	1
Material Fragmentation	1	1
Stretched	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Injury	454	454
Pain	266	266
Failure of Implant	213	213
No Code Available	148	148
Unspecified Infection	116	116
Cyst(s)	110	110
No Known Impact Or Consequence To Patient	85	85
Bone Fracture(s)	66	66
Implant Pain	53	53
Arthritis	47	47
Osteolysis	46	46
No Information	45	45
Insufficient Information	36	36
Post Operative Wound Infection	33	33
Impaired Healing	29	29
Swelling	29	29
Loss of Range of Motion	22	22
Bacterial Infection	20	20
Ossification	20	20
Deformity/ Disfigurement	19	19
Wound Dehiscence	19	19
Death	19	19
Ambulation Difficulties	18	18
Inadequate Osseointegration	15	15
Necrosis	13	13
Inflammation	13	13
Joint Laxity	12	12
Non-union Bone Fracture	11	11
Erythema	10	10
Tissue Damage	9	9
Capsular Contracture	9	9
Limited Mobility Of The Implanted Joint	9	9
Fall	8	8
Swelling/ Edema	7	7
Discomfort	7	7
Numbness	6	6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	6	6
Arthralgia	6	6
No Clinical Signs, Symptoms or Conditions	6	6
Nerve Damage	5	5
Irritation	4	4
Reaction	4	4
Scar Tissue	4	4
Pulmonary Embolism	3	3
Inadequate Pain Relief	3	3
Hypersensitivity/Allergic reaction	3	3
Joint Dislocation	3	3
Joint Disorder	3	3
Test Result	3	3
Joint Swelling	3	3