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)
2019	2020	2021	2022	2023	2024
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	989	989
Biocompatibility	717	717
Appropriate Term/Code Not Available	317	317
Patient Device Interaction Problem	310	310
Insufficient Information	131	131
Compatibility Problem	83	83
Break	72	72
Loosening of Implant Not Related to Bone-Ingrowth	56	56
Fracture	40	40
Loose or Intermittent Connection	38	38
Corroded	34	34
Noise, Audible	30	30
Migration	30	30
Device Appears to Trigger Rejection	27	27
Device Dislodged or Dislocated	26	26
Material Fragmentation	26	26
Loss of Osseointegration	22	22
Naturally Worn	20	20
Patient-Device Incompatibility	20	20
Degraded	18	18
Malposition of Device	14	14
Device Slipped	9	9
Unstable	8	8
Mechanical Problem	8	8
Material Disintegration	8	8
Therapeutic or Diagnostic Output Failure	8	8
Material Twisted/Bent	6	6
Defective Device	5	5
Pitted	4	4
Inadequacy of Device Shape and/or Size	4	4
No Apparent Adverse Event	4	4
Collapse	4	4
Dull, Blunt	4	4
Detachment of Device or Device Component	3	3
Material Erosion	3	3
Improper or Incorrect Procedure or Method	3	3
Osseointegration Problem	3	3
Crack	3	3
Material Discolored	2	2
Use of Device Problem	2	2
Failure to Osseointegrate	2	2
Material Separation	2	2
Unintended Movement	2	2
Connection Problem	2	2
Migration or Expulsion of Device	2	2
Contamination /Decontamination Problem	1	1
Positioning Failure	1	1
Component Missing	1	1
Failure to Align	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Metal Related Pathology	953	953
Pain	879	879
Injury	472	472
Toxicity	325	326
Failure of Implant	309	309
Test Result	176	176
Loss of Range of Motion	148	148
Osteolysis	136	136
Infiltration into Tissue	123	123
No Code Available	93	93
No Clinical Signs, Symptoms or Conditions	91	91
Unspecified Infection	89	89
Discomfort	79	79
Ambulation Difficulties	79	79
Arthralgia	78	78
Insufficient Information	76	76
Bone Fracture(s)	62	62
Inflammation	60	60
Cyst(s)	58	58
No Known Impact Or Consequence To Patient	54	54
Necrosis	51	51
Joint Dislocation	49	49
Hip Fracture	47	47
Inadequate Osseointegration	45	45
Limited Mobility Of The Implanted Joint	43	43
Synovitis	41	41
Swelling	35	35
Foreign Body Reaction	34	34
Implant Pain	34	34
Reaction	33	33
Joint Laxity	29	29
Unequal Limb Length	27	27
Debris, Bone Shedding	27	27
No Information	26	26
Solid Tumour	23	23
Swelling/ Edema	22	22
Ossification	21	21
Tissue Damage	20	20
Deformity/ Disfigurement	19	19
Unspecified Tissue Injury	16	16
Neuralgia	15	15
Fall	15	15
Bacterial Infection	14	14
Osteopenia/ Osteoporosis	13	13
Memory Loss/Impairment	12	12
Fatigue	10	10
Tissue Breakdown	9	9
Hematoma	9	9
Muscle Weakness	9	9
Muscular Rigidity	8	8

Recalls
Manufacturer		Recall Class	Date Posted
1	Smith & Nephew Orthopaedics Ltd. (Aurora)	II	Aug-11-2021