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	5
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	1483	1483
Osseointegration Problem	742	742
Insufficient Information	633	633
Migration	451	451
Loss of Osseointegration	94	94
Break	66	66
Fracture	63	63
Loosening of Implant Not Related to Bone-Ingrowth	62	62
Naturally Worn	38	38
Appropriate Term/Code Not Available	34	34
Malposition of Device	30	30
Device Dislodged or Dislocated	30	30
Inadequacy of Device Shape and/or Size	21	21
Use of Device Problem	20	20
Unstable	18	18
Unintended Movement	16	16
Failure to Osseointegrate	15	15
Device Difficult to Setup or Prepare	13	13
Detachment of Device or Device Component	12	12
Positioning Failure	11	11
Biocompatibility	10	10
Patient Device Interaction Problem	10	10
Off-Label Use	9	9
Patient-Device Incompatibility	9	9
Defective Device	8	8
Loss of or Failure to Bond	6	6
Mechanical Jam	6	6
Inaccurate Information	6	6
Component Missing	6	6
Improper or Incorrect Procedure or Method	5	5
Material Deformation	5	5
Device Handling Problem	4	4
Material Fragmentation	4	4
Positioning Problem	4	4
Material Discolored	3	3
Degraded	3	3
Device Damaged by Another Device	2	2
Material Separation	2	2
Shipping Damage or Problem	2	2
No Apparent Adverse Event	2	2
Nonstandard Device	2	2
Device Markings/Labelling Problem	2	2
Crack	2	2
Device-Device Incompatibility	2	2
Material Twisted/Bent	1	1
Failure to Align	1	1
Difficult to Insert	1	1
Difficult or Delayed Positioning	1	1
Misassembly by Users	1	1
Residue After Decontamination	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Insufficient Information	1076	1076
Inadequate Osseointegration	848	848
Implant Pain	530	530
Cyst(s)	487	487
Unspecified Infection	330	330
Failure of Implant	170	170
Pain	157	157
No Clinical Signs, Symptoms or Conditions	156	156
Swelling/ Edema	141	141
Loss of Range of Motion	116	116
Osteolysis	112	112
Bone Fracture(s)	104	104
Injury	87	87
Limb Fracture	79	79
Wound Dehiscence	76	76
Ambulation Difficulties	61	61
Patient Problem/Medical Problem	57	57
Post Operative Wound Infection	45	45
Impaired Healing	36	36
Discomfort	35	35
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	34	34
Ossification	32	32
Joint Laxity	30	30
Bacterial Infection	26	26
Deformity/ Disfigurement	24	24
Arthritis	22	22
Subluxation	22	22
Joint Dislocation	18	18
Numbness	18	18
Inflammation	17	17
Fluid Discharge	17	17
Erythema	15	15
No Code Available	14	14
Nerve Damage	13	13
Scar Tissue	13	13
Fall	12	12
Osteopenia/ Osteoporosis	11	11
Malunion of Bone	10	10
Necrosis	8	8
Unspecified Tissue Injury	8	8
Foreign Body Reaction	8	8
Rheumatoid Arthritis	8	8
No Information	7	7
Purulent Discharge	7	7
Fever	7	7
Arthralgia	7	7
Ankylosis	6	6
Foreign Body In Patient	6	6
Damage to Ligament(s)	6	6
Neuropathy	5	5

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