TPLC - Total Product Life Cycle

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Device	prosthesis, hip, semi-constrained, metal/metal, resurfacing
Definition	Prosthesis, hip, semi-constrained, metal/metal, resurfacing device relieves hip pain and improves hip function by replacing the parts of the hip that have been severely damaged by degenerative joint diseases. This device is indicated for patients with degenerative joint diseases including osteoarthritis, rheumatoid arthritis, traumatic arthritis, dysplasia, or avascular necrosis and for patients who, due to their relatively younger age or increased activity level, may not be suitable for traditional total hip replacement due to an increased possibility of requiring future hip joint revision.
Product Code	NXT
Device Class	3

Premarket Approvals (PMA)
2009	2010	2011	2012	2013	2014	2015	2016	2017	2018	2019	2020	2021	2022	2023	2024
9	4	7	1	1	5	2	3	1	2	0	1	0	1	1	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	1600	1600
Insufficient Information	1141	1141
Appropriate Term/Code Not Available	1059	1059
Biocompatibility	719	719
Patient Device Interaction Problem	435	435
Metal Shedding Debris	197	197
Device Operates Differently Than Expected	150	150
Patient-Device Incompatibility	140	140
Break	91	91
Loose or Intermittent Connection	89	89
Fracture	86	86
Compatibility Problem	84	84
Noise, Audible	82	82
Device Dislodged or Dislocated	66	66
Loosening of Implant Not Related to Bone-Ingrowth	57	57
Device Slipped	53	53
Corroded	49	49
Material Fragmentation	42	42
Material Integrity Problem	41	41
Naturally Worn	38	38
Malposition of Device	32	32
Migration	31	31
Device Appears to Trigger Rejection	27	27
Loss of Osseointegration	24	24
Mechanical Problem	24	24
Degraded	23	23
Unstable	20	20
Material Disintegration	19	19
Unintended Movement	16	16
Migration or Expulsion of Device	11	11
Collapse	10	10
Therapeutic or Diagnostic Output Failure	9	9
Inadequacy of Device Shape and/or Size	8	8
Improper or Incorrect Procedure or Method	8	8
Detachment of Device or Device Component	6	6
Pitted	6	6
Material Twisted/Bent	6	6
No Apparent Adverse Event	5	5
Protective Measures Problem	5	5
Nonstandard Device	5	5
Material Discolored	5	5
Crack	5	5
Defective Device	5	5
Material Erosion	5	5
Connection Problem	4	4
Failure To Adhere Or Bond	4	4
Detachment Of Device Component	4	4
Dull, Blunt	4	4
Use of Device Problem	3	3
Component Missing	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	1838	1839
Toxicity	1227	1229
Metal Related Pathology	956	956
No Code Available	868	869
Failure of Implant	843	843
Injury	786	786
Test Result	424	425
Osteolysis	214	214
Reaction	205	205
Loss of Range of Motion	168	168
Swelling	168	168
Weakness	153	153
No Known Impact Or Consequence To Patient	138	138
Unspecified Infection	137	137
Ambulation Difficulties	133	133
Infiltration into Tissue	124	124
Discomfort	123	123
No Information	119	119
Necrosis	107	107
Bone Fracture(s)	99	100
Inflammation	99	99
No Clinical Signs, Symptoms or Conditions	91	91
Arthralgia	87	87
Insufficient Information	78	78
Joint Dislocation	75	75
Joint Swelling	73	73
Cyst(s)	72	72
Limited Mobility Of The Implanted Joint	68	68
Tissue Damage	67	67
Muscle Weakness	63	63
Synovitis	56	56
Hip Fracture	55	55
Debris, Bone Shedding	54	54
Inadequate Osseointegration	45	45
Foreign Body Reaction	42	42
Complaint, Ill-Defined	40	40
Implant Pain	34	34
Hypersensitivity/Allergic reaction	30	30
Fall	30	30
Joint Laxity	29	29
Unequal Limb Length	27	27
Host-Tissue Reaction	25	25
Ossification	25	25
Solid Tumour	23	23
Chemical Exposure	23	23
Swelling/ Edema	22	22
Foreign Body In Patient	21	21
Deformity/ Disfigurement	19	19
Fatigue	18	18
Bacterial Infection	18	18

Recalls
Manufacturer		Recall Class	Date Posted
1	Smith & Nephew Orthopaedics Ltd. (Aurora)	II	Aug-11-2021
2	Smith & Nephew, Inc.	II	May-21-2018
3	Smith & Nephew, Inc.	II	Sep-10-2015