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	2
IN2BONES SAS
	SUBSTANTIALLY EQUIVALENT	3
PARAGON 28, INC.
	SUBSTANTIALLY EQUIVALENT	5
RESTOR3D
	SUBSTANTIALLY EQUIVALENT	4
RESTOR3D, INC.
	SUBSTANTIALLY EQUIVALENT	1
VILEX, LLC
	SUBSTANTIALLY EQUIVALENT	2
WRIGHT MEDICAL TECHNOLOGY, INC. (STRYKER)
	SUBSTANTIALLY EQUIVALENT	2
1. K241999 Prophecy Surgical Planning System
2. K250037 Incompass Total Ankle System
WRIGHTMEDICALTECHNOLOGYINC
	SUBSTANTIALLY EQUIVALENT	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	2173	2173
Osseointegration Problem	1101	1101
Insufficient Information	1037	1037
Migration	505	505
Loss of Osseointegration	177	177
Fracture	99	99
Loosening of Implant Not Related to Bone-Ingrowth	78	79
Break	70	70
Malposition of Device	56	56
Naturally Worn	56	56
Inadequacy of Device Shape and/or Size	48	48
Appropriate Term/Code Not Available	37	37
Device Dislodged or Dislocated	35	36
Unstable	33	33
Positioning Failure	23	23
Unintended Movement	21	21
Failure to Osseointegrate	21	21
Detachment of Device or Device Component	17	17
Use of Device Problem	16	16
Device Difficult to Setup or Prepare	14	14
Biocompatibility	10	10
Off-Label Use	10	10
Patient Device Interaction Problem	9	9
Defective Device	8	8
Patient-Device Incompatibility	7	7
Material Fragmentation	6	6
Mechanical Jam	6	6
Inaccurate Information	6	6
Positioning Problem	6	6
Component Missing	6	6
Material Deformation	6	6
Structural Problem	4	4
Device Handling Problem	4	4
Improper or Incorrect Procedure or Method	3	3
Material Discolored	3	3
Device Appears to Trigger Rejection	3	3
Collapse	3	3
No Apparent Adverse Event	3	3
Loss of or Failure to Bond	2	2
Crack	2	2
Device Markings/Labelling Problem	2	2
Nonstandard Device	2	2
Defective Component	2	2
Material Separation	2	2
Lack of Effect	2	2
Device Damaged by Another Device	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Shipping Damage or Problem	2	2
Difficult to Insert	2	2
Degraded	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Insufficient Information	1586	1586
Inadequate Osseointegration	1275	1275
Cyst(s)	733	733
Implant Pain	593	594
Pain	505	505
Unspecified Infection	415	415
Swelling/ Edema	191	191
Loss of Range of Motion	186	186
Osteolysis	181	181
No Clinical Signs, Symptoms or Conditions	166	166
Failure of Implant	157	158
Bone Fracture(s)	144	144
Ossification	129	129
Post Operative Wound Infection	120	120
Limb Fracture	107	107
Wound Dehiscence	89	89
Ambulation Difficulties	86	86
Subluxation	58	58
Joint Laxity	58	58
Bacterial Infection	57	57
Impaired Healing	51	51
Discomfort	49	49
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	38	38
Deformity/ Disfigurement	37	37
Arthritis	35	35
Numbness	31	31
Fall	26	26
Cellulitis	26	26
Joint Dislocation	22	22
Fluid Discharge	21	21
Inflammation	21	21
Nerve Damage	17	17
Malunion of Bone	17	17
Scar Tissue	15	15
Erythema	14	14
Necrosis	12	12
Capsular Contracture	12	12
Joint Contracture	11	11
Osteopenia/ Osteoporosis	11	11
Unspecified Tissue Injury	10	10
Muscle/Tendon Damage	10	10
Fever	10	10
Ankylosis	9	9
Rheumatoid Arthritis	9	9
Neuropathy	9	9
Metal Related Pathology	8	8
Foreign Body Reaction	8	8
Damage to Ligament(s)	8	8
Osteomyelitis	8	8
Foreign Body In Patient	8	8

Recalls
Manufacturer		Recall Class	Date Posted
1	Exactech, Inc.	II	Jan-18-2024
2	Exactech, Inc.	II	Oct-04-2021
3	Wright Medical Technology Inc	II	Dec-01-2021
4	Wright Medical Technology, Inc.	II	Apr-04-2024
5	Wright Medical Technology, Inc.	II	Jul-07-2023
6	Wright Medical Technology, Inc.	II	Oct-27-2022
7	Wright Medical Technology, Inc.	II	Jun-27-2022