TPLC - Total Product Life Cycle

show TPLC since

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	3
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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	1664	1664
Osseointegration Problem	818	818
Insufficient Information	727	727
Migration	480	480
Loss of Osseointegration	101	101
Fracture	74	74
Break	72	72
Loosening of Implant Not Related to Bone-Ingrowth	65	65
Naturally Worn	43	43
Malposition of Device	38	38
Appropriate Term/Code Not Available	35	35
Device Dislodged or Dislocated	33	33
Inadequacy of Device Shape and/or Size	25	25
Unintended Movement	22	22
Unstable	21	21
Use of Device Problem	20	20
Failure to Osseointegrate	16	16
Positioning Failure	13	13
Device Difficult to Setup or Prepare	13	13
Detachment of Device or Device Component	12	12
Biocompatibility	10	10
Patient-Device Incompatibility	10	10
Patient Device Interaction Problem	10	10
Off-Label Use	9	9
Defective Device	8	8
Component Missing	7	7
Loss of or Failure to Bond	6	6
Mechanical Jam	6	6
Inaccurate Information	6	6
Improper or Incorrect Procedure or Method	5	5
Material Deformation	5	5
Device Handling Problem	4	4
Positioning Problem	4	4
Material Fragmentation	4	4
Material Discolored	3	3
Degraded	3	3
No Apparent Adverse Event	2	2
Material Separation	2	2
Shipping Damage or Problem	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Nonstandard Device	2	2
Crack	2	2
Device Markings/Labelling Problem	2	2
Device Damaged by Another Device	2	2
Device-Device Incompatibility	2	2
Lack of Effect	1	1
Failure to Convert Rhythm	1	1
Misassembly by Users	1	1
Material Twisted/Bent	1	1
Material Integrity Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Insufficient Information	1176	1176
Inadequate Osseointegration	936	936
Implant Pain	570	570
Cyst(s)	540	540
Unspecified Infection	373	373
Pain	215	215
Failure of Implant	175	175
No Clinical Signs, Symptoms or Conditions	158	158
Swelling/ Edema	156	156
Loss of Range of Motion	138	138
Osteolysis	126	126
Bone Fracture(s)	121	121
Injury	87	87
Limb Fracture	83	83
Wound Dehiscence	82	82
Ambulation Difficulties	66	66
Patient Problem/Medical Problem	57	57
Post Operative Wound Infection	53	53
Bacterial Infection	49	49
Discomfort	42	42
Subluxation	40	40
Impaired Healing	39	39
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	35	35
Joint Laxity	35	35
Ossification	35	35
Deformity/ Disfigurement	26	26
Arthritis	22	22
Joint Dislocation	18	18
Numbness	18	18
Fluid Discharge	17	17
Inflammation	17	17
Nerve Damage	16	16
Erythema	15	15
No Code Available	14	14
Scar Tissue	13	13
Fall	12	12
Osteopenia/ Osteoporosis	11	11
Malunion of Bone	10	10
Fever	10	10
Rheumatoid Arthritis	9	9
Necrosis	8	8
Unspecified Tissue Injury	8	8
Foreign Body Reaction	8	8
Foreign Body In Patient	7	7
Purulent Discharge	7	7
No Information	7	7
Arthralgia	7	7
Damage to Ligament(s)	6	6
Capsular Contracture	6	6
Ankylosis	6	6

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