TPLC - Total Product Life Cycle

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

Premarket Reviews
Manufacturer	Decision
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	6
RESTOR3D
	SUBSTANTIALLY EQUIVALENT	4
RESTOR3D, INC.
	SUBSTANTIALLY EQUIVALENT	1
VILEX, LLC
	SUBSTANTIALLY EQUIVALENT	2
WRIGHT MEDICAL TECHNOLOGY, INC (STRYKER)
	SUBSTANTIALLY EQUIVALENT	1
WRIGHT MEDICAL TECHNOLOGY, INC.
	SUBSTANTIALLY EQUIVALENT	3
WRIGHT MEDICAL TECHNOLOGY, INC. (STRYKER)
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	1893	1893
Osseointegration Problem	954	954
Insufficient Information	890	890
Migration	500	500
Loss of Osseointegration	120	120
Fracture	89	89
Break	77	77
Loosening of Implant Not Related to Bone-Ingrowth	71	71
Naturally Worn	51	51
Malposition of Device	46	46
Inadequacy of Device Shape and/or Size	41	41
Device Dislodged or Dislocated	37	37
Appropriate Term/Code Not Available	35	35
Unstable	28	28
Unintended Movement	22	22
Use of Device Problem	21	21
Failure to Osseointegrate	17	17
Detachment of Device or Device Component	15	15
Positioning Failure	15	15
Patient Device Interaction Problem	13	13
Device Difficult to Setup or Prepare	13	13
Biocompatibility	10	10
Off-Label Use	10	10
Patient-Device Incompatibility	10	10
Defective Device	8	8
Component Missing	7	7
Loss of or Failure to Bond	6	6
Mechanical Jam	6	6
Improper or Incorrect Procedure or Method	6	6
Inaccurate Information	6	6
Material Deformation	6	6
Material Fragmentation	6	6
Positioning Problem	5	5
Device Handling Problem	4	4
Material Discolored	3	3
Degraded	3	3
Shipping Damage or Problem	2	2
Difficult to Insert	2	2
Structural Problem	2	2
Device Damaged by Another Device	2	2
Lack of Effect	2	2
Material Separation	2	2
No Apparent Adverse Event	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Nonstandard Device	2	2
Device Markings/Labelling Problem	2	2
Crack	2	2
Device-Device Incompatibility	2	2
Failure to Align	1	1
Material Twisted/Bent	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Insufficient Information	1388	1388
Inadequate Osseointegration	1088	1088
Cyst(s)	607	607
Implant Pain	584	584
Unspecified Infection	395	395
Pain	371	371
Failure of Implant	176	176
Swelling/ Edema	174	174
No Clinical Signs, Symptoms or Conditions	166	166
Loss of Range of Motion	163	163
Osteolysis	148	148
Bone Fracture(s)	142	142
Limb Fracture	87	87
Injury	87	87
Wound Dehiscence	85	85
Ambulation Difficulties	71	71
Post Operative Wound Infection	71	71
Patient Problem/Medical Problem	57	57
Bacterial Infection	57	57
Ossification	57	57
Subluxation	49	49
Impaired Healing	46	46
Joint Laxity	45	45
Discomfort	43	43
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	36	36
Numbness	28	28
Deformity/ Disfigurement	26	26
Arthritis	22	22
Joint Dislocation	21	21
Inflammation	21	21
Fall	18	18
Fluid Discharge	17	17
Nerve Damage	17	17
Scar Tissue	15	15
Erythema	15	15
No Code Available	14	14
Osteopenia/ Osteoporosis	11	11
Malunion of Bone	10	10
Fever	10	10
Necrosis	10	10
Rheumatoid Arthritis	9	9
Muscle/Tendon Damage	9	9
Damage to Ligament(s)	8	8
Foreign Body Reaction	8	8
Osteomyelitis	8	8
Unspecified Tissue Injury	8	8
Ankylosis	8	8
Purulent Discharge	7	7
Foreign Body In Patient	7	7
No Information	7	7

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	Wright Medical Technology Inc	II	Dec-01-2021
5	Wright Medical Technology Inc	II	May-07-2020
6	Wright Medical Technology, Inc.	II	Apr-04-2024
7	Wright Medical Technology, Inc.	II	Jul-07-2023
8	Wright Medical Technology, Inc.	II	Oct-27-2022
9	Wright Medical Technology, Inc.	II	Jun-27-2022