TPLC - Total Product Life Cycle

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Device	prosthesis, ankle, semi-constrained, cemented, metal/polymer
Product Code	HSN
Regulation Number	888.3110
Device Class	2

Premarket Reviews
Manufacturer	Decision
EXACTECH INC
	SUBSTANTIALLY EQUIVALENT	1
EXACTECH INC.
	SUBSTANTIALLY EQUIVALENT	1
EXACTECH, INC.
	SUBSTANTIALLY EQUIVALENT	1
IN2BONES SAS
	SUBSTANTIALLY EQUIVALENT	4
INTEGRA LIFESCIENCES CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
KINOS MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
PARAGON 28, INC
	SUBSTANTIALLY EQUIVALENT	1
PARAGON 28, INC.
	SUBSTANTIALLY EQUIVALENT	5
RESTOR3D
	SUBSTANTIALLY EQUIVALENT	2
RESTOR3D, INC.
	SUBSTANTIALLY EQUIVALENT	1
VILEX, LLC
	SUBSTANTIALLY EQUIVALENT	1
WRIGHT MEDICAL TECHNOLOGY, INC.
	SUBSTANTIALLY EQUIVALENT	4

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	1286	1286
Osseointegration Problem	512	512
Insufficient Information	457	457
Migration	419	419
Loss of Osseointegration	127	127
Break	67	67
Loosening of Implant Not Related to Bone-Ingrowth	58	58
Fracture	54	54
Appropriate Term/Code Not Available	38	38
Device Dislodged or Dislocated	36	36
Malposition of Device	29	29
Loss of or Failure to Bond	27	27
Naturally Worn	26	26
Use of Device Problem	20	20
Detachment of Device or Device Component	16	16
Unintended Movement	16	16
Unstable	16	16
Failure to Osseointegrate	14	14
Device Difficult to Setup or Prepare	13	13
Patient Device Interaction Problem	12	12
Inadequacy of Device Shape and/or Size	12	12
Improper or Incorrect Procedure or Method	9	9
Positioning Failure	9	9
Defective Device	8	8
Patient-Device Incompatibility	8	8
Off-Label Use	8	8
Mechanical Jam	6	6
Positioning Problem	5	5
Inaccurate Information	5	5
Component Missing	5	5
No Apparent Adverse Event	4	4
Device Handling Problem	4	4
Material Deformation	4	4
Degraded	4	4
Material Fragmentation	3	3
Loose or Intermittent Connection	3	3
Material Erosion	2	2
Device Damaged by Another Device	2	2
Collapse	2	2
Material Discolored	2	2
Material Separation	2	2
Device Markings/Labelling Problem	2	2
Peeled/Delaminated	2	2
Mechanical Problem	2	2
Nonstandard Device	2	2
Device-Device Incompatibility	2	2
Failure to Align	1	1
Material Twisted/Bent	1	1
Difficult or Delayed Positioning	1	1
Misassembled	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Insufficient Information	853	853
Inadequate Osseointegration	639	639
Cyst(s)	400	400
Implant Pain	367	367
Unspecified Infection	260	260
Injury	170	170
Pain	169	169
Failure of Implant	156	156
No Clinical Signs, Symptoms or Conditions	141	141
No Code Available	121	121
Bone Fracture(s)	108	108
Swelling/ Edema	101	101
Osteolysis	83	83
Limb Fracture	73	73
Patient Problem/Medical Problem	67	67
Loss of Range of Motion	67	67
Post Operative Wound Infection	47	47
No Known Impact Or Consequence To Patient	43	43
Ambulation Difficulties	39	39
Impaired Healing	37	37
Wound Dehiscence	37	37
Ossification	36	36
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	29	29
Bacterial Infection	26	26
Joint Dislocation	25	25
Deformity/ Disfigurement	22	22
Arthritis	19	19
Joint Laxity	19	19
Discomfort	19	19
Fluid Discharge	17	17
No Information	15	15
Numbness	14	14
Inflammation	13	13
Erythema	12	12
Fall	12	12
Osteopenia/ Osteoporosis	10	10
Rheumatoid Arthritis	8	8
Tissue Damage	8	8
Unspecified Tissue Injury	8	8
Necrosis	7	7
Purulent Discharge	7	7
Foreign Body In Patient	7	7
Arthralgia	7	7
Scar Tissue	7	7
Damage to Ligament(s)	6	6
Ankylosis	6	6
Foreign Body Reaction	5	5
Nerve Damage	5	5
Adhesion(s)	4	4
Non-union Bone Fracture	4	4

Recalls
Manufacturer		Recall Class	Date Posted
1	Exactech, Inc.	II	Jan-18-2024
2	Exactech, Inc.	II	Oct-04-2021
3	Exactech, Inc.	II	Aug-31-2020
4	Integra LifeSciences Corp.	II	Apr-16-2019
5	Wright Medical Technology Inc	II	Dec-01-2021
6	Wright Medical Technology Inc	II	May-07-2020
7	Wright Medical Technology, Inc.	II	Apr-04-2024
8	Wright Medical Technology, Inc.	II	Jul-07-2023
9	Wright Medical Technology, Inc.	II	Oct-27-2022
10	Wright Medical Technology, Inc.	II	Jun-27-2022
11	Wright Medical Technology, Inc.	II	Nov-25-2019
12	Zimmer Biomet, Inc.	II	Nov-07-2019